Primary Device ID | 10814639023302 |
NIH Device Record Key | 91b2b015-f624-40bb-9bf9-9006953e242f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UNIFY PGCL Surgical Sutures |
Version Model Number | S-Q418XR13 |
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 |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com | |
Phone | 1-888-841-8481 |
info.usa@ad-surgical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814639023305 [Primary] |
GS1 | 10814639023302 [Package] Contains: 00814639023305 Package: Box [36 Units] In Commercial Distribution |
GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-04-20 |
Device Publish Date | 2023-04-12 |
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. |