DW-1C

GUDID 08800050100000

DongWon Medical CO.,LTD.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Primary Device ID	08800050100000
NIH Device Record Key	e31ead0c-8da8-4b25-af33-fc02b6110e9b
Commercial Distribution Status	In Commercial Distribution
Brand Name	DW-1C
Version Model Number	DWFA-1C
Company DUNS	690412950
Company Name	DongWon Medical CO.,LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	43 Centimeter
Length	43 Centimeter
Length	43 Centimeter
Length	43 Centimeter
Length	43 Centimeter
Length	43 Centimeter
Length	43 Centimeter
Length	43 Centimeter
Length	43 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800050100000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160761

FDA Product Code

NEW	Suture, Surgical, Absorbable, Polydioxanone

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2021-02-05
Device Publish Date	2019-03-20