| Primary Device ID | 20814639023774 |
| NIH Device Record Key | 5dff3212-17c4-4f51-8f77-9bdabe9c82f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium UNIFY PDO Sutures |
| Version Model Number | PLD-327R24 |
| 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 | 00814639023770 [Primary] |
| GS1 | 10814639023777 [Package] Contains: 00814639023770 Package: box [12 Units] In Commercial Distribution |
| GS1 | 20814639023774 [Package] Contains: 10814639023777 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 | 2 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2018-08-13 |
| 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" |