Primary Device ID | 20814639022692 |
NIH Device Record Key | 48f78236-33dc-426e-84c9-36fa3ab834c9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Premium UNIFY PDO Sutures |
Version Model Number | PSD-418R13 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814639022698 [Primary] |
GS1 | 10814639022695 [Package] Contains: 00814639022698 Package: box [12 Units] In Commercial Distribution |
GS1 | 20814639022692 [Package] Contains: 10814639022695 Package: case [100 Units] In Commercial Distribution |
NEW | Suture, Surgical, Absorbable, Polydioxanone |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-02-07 |
Device Publish Date | 2016-11-03 |
20814639023842 | Premium PDO, Med 3-0, 19mm 3/8 Cir Rev Cut, Violet, 18" |
20814639023835 | Premium PDO Suture, Size 4-0, 24mm 3/8 Cir Rev Cut, Violet, 27" |
20814639023774 | Premium PDO Suture, Size 3-0, 24mm 3/8 Cir Rev Cut, Violet, 27" |
20814639022715 | Premium UNIFY PDO Sutures, Sm 6-0, 13mm 3/8 circle Rev Cut, 18" |
20814639022708 | Premium UNIFY PDO Sutures, Sm 5-0, 13mm 3/8 circle Rev Cut, 18" |
20814639022692 | Premium UNIFY PDO Sutures, Sm 4-0, 13mm 3/8 circle Rev Cut, 18" |
20814639022685 | Premium UNIFY PDO Sutures, Med 5-0, 19mm 3/8 circle Rev Cut, 18" |
20814639022678 | Premium UNIFY PDO Sutures, Med 4-0, 19mm 3/8 circle Rev Cut, 18" |
20814639022661 | Premium UNIFY PDO Sutures, Med 5-0, 16mm 3/8 circle Rev Cut, 18" |
20814639022654 | Premium UNIFY PDO Sutures, Med 4-0, 16mm 3/8 circle Rev Cut, 18" |
10814639023272 | Premium PDO, Med 2-0, 19mm 3/8 Cir Rev Cut, Violet, 18" |
10814639025993 | Premium PDO, Med 4-0, 19mm 3/8 Cir Rev Cut, Violet, 27" |
10814639025986 | Premium PDO, Med 3-0, 19mm 3/8 Cir Rev Cut, Violet, 27" |
10814639025979 | Premium PDO, Med 2-0, 19mm 3/8 Cir Rev Cut, Violet, 27" |
10814639025962 | Premium PDO Suture, Size 2-0, 24mm 3/8 Cir Rev Cut, Violet, 27" |