Doc. No.

HD - DDF - 03-06
DESIGN DOSSIER FILE Rev. No. 0

RAW MATERIAL
 Rev. Date. 2016. 1. 15.

STERILE SINGLE USE ABSORBALE POLYDIOXANONE
SUTURE WITH NEEDLE (DREAM UP) Page 1 of 3

HYUNDAE MEDITECH Co., Ltd.

DESIGN DOSSIER FILE

Raw Material

Approval of the Raw Material is performed in accordance with the responsibility of the following functional area representatives.

The following product applies ClassIII according to Council Directive 93/42/EEC amended by 07/47/EEC AnnexIX Rule7.


STERILIAE SINGLE USE ABSORBABLE POLYDIOXANONE SUTURE WITH NEEDLE

Product Name (DREAM UP)

Reference - See annex Model code list

Revision History


Rev. No. Rev. Date. Modified Contents Remark

0 January 15, 2016. Establishment -

Attached File Information


No. Attached File No. File Name Location

1 HD-DDF-03-06-01 Annex of Raw Material Annex

Division Department Name Date Signature

Authored by Quality Assurance Team Hong Ryun Hee January 15, 2016.

Reviewed by Quality Assurance Team Kim Gi Young January 15, 2016.

Approved by President Song Mi Hee January 15, 2016.

Functional Area Representatives


Preparation, Review and Approval of the document was performed by the organization that had been approved by our company.

DESIGN DOSSIER FILE 1 of 3 Hyundai Meditech Co., Ltd.

 Doc. No. HD - DDF - 03-06
DESIGN DOSSIER FILE Rev. No. 0
RAW MATERIAL
 Rev. Date. 2016. 1. 15.
STERILE SINGLE USE ABSORBALE POLYDIOXANONE
SUTURE WITH NEEDLE (DREAM UP) Page 2 of 3

TABLE OF CONTENTS

1. Raw Material Table

2. Raw Material

3. Additional Material In Process

DESIGN DOSSIER FILE 2 of 3 Hyundai Meditech Co., Ltd.

 Doc. No. HD - DDF - 03-06
DESIGN DOSSIER FILE Rev. No. 0
RAW MATERIAL
 Rev. Date. 2016. 1. 15.
STERILE SINGLE USE ABSORBALE POLYDIOXANONE
SUTURE WITH NEEDLE (DREAM UP) Page 3 of 3


1. Raw Material Table
1) HD(“Dream Up” DUM), HDS(“Dream Up” DUMS), HDTW(“Dream Up” DUT), HDTWS(“Dream Up” DUTS),
HMC(“Dream Up” DURU, DURC, DUMRU, DUMRC, DUMRUP, DUMRUPM, DUNUP, DURU-H/P, DURUP-H/
P, DURUPM-H/P, DUMRU-H/P, DUMRUP-H/P, DUMRUPM-H/P) Series #

No. Part Name Material Standard Manufacturer

Poly Samyang Biopharmaceuticals

1 Suture CAS No. 29223-92-5 Corporation
(1.4-dioxanone-2-one)
(EN ISO 13485:2012, Certificate No. 13 0388 SJ/a by ITC)

2 Needle Stainless Steel KS D3703 (STS 304) Yong Chang Co.

(EN ISO 13485:2012, Certificate No. 15 0125 JS by ITC)

3 Hub Polypropylene Homo CAS No. 9003-07-0 Hyosung Chemicals

Polymer

Honam Petrochemical
4 Needle Cap Polyolefin CAS No. 9003-07-0
Corporation

5 Sponge Polyurethane CAS No. 9002-88-4 VOCO GmbH

(EN ISO 13485:2003+AC:2009,
Certificate No. 0675GB434120109 by MEDCERT)

2. Raw Material
2.1. Suture
- Polydioxanone (PDO)
- Monomer (P-dioxanone) : ≤ 1 wt. %
- Catalyst (Tin) : ≤ 100ppm
- Heavy metal : ≤ 10ppm
- Stabilizing agents : None
- Antioxidizing agents : None
- The other ingredients identified by NMR.
- Manufacturer : Samyang Biopharmaceutical Corporation
2.1. Needle
- Stainless Steel (STS 304)
- Single-use needle
- Manufacturer : Yong Chang Co.

2. Additional Material In Process

No. Material Standard

ISO 10993-7 : Biological evaluation of medical device


1 Ethylene Oxide Gas
- Part 7 : Ethylene oxide sterilization residuals

DESIGN DOSSIER FILE 3 of 3 Hyundai Meditech Co., Ltd.