UNIFY PGCL Surgical Sutures

GUDID 10814639022329

Poliglecaprone suture Poliglecaprone suture

Primary Device ID	10814639022329
NIH Device Record Key	10f8e119-d917-466a-adf9-daa619ba7ced
Commercial Distribution Status	In Commercial Distribution
Brand Name	UNIFY PGCL Surgical Sutures
Version Model Number	S-Q418R13-C
Company DUNS	017524666
Company Name	APPLIED DENTAL, INC.
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	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00814639022322 [Primary]
GS1	10814639022329 [Package] Contains: 00814639022322 Package: Box [12 Units] In Commercial Distribution
GS1	20814639022326 [Package] Package: case [100 Units] In Commercial Distribution

GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid

Steralize Prior To Use	false
Device Is Sterile	true

10814639022329	PGCL Sutures, Absorbable, Sm, 4-0, 13mm 3/8 Circle Rev Cut, 18" Violet color.
00814639021790	PGCL, Absorbable, Sm, 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
10814639025856	PGCL, Absorbable, Sm, 5-0, 13mm 3/8 Circle Rev Cut, 18" Violet. 1 pc of 3 Dzn.
10814639025849	PGCL, Absorbable, Sm, 5-0, 13mm 3/8 Circle Rev Cut, 18" Undyed. 1 pc of 3 Dzn.
10814639023302	PGCL, Absorbable, Sm, 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed. 1 pc of 3 Dzn.