| Primary Device ID | 10814639026754 |
| NIH Device Record Key | bd9a2b68-fa2b-4e22-aecd-e005e653b283 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium UNIFY Silk Sutures |
| Version Model Number | PMS-418R19 |
| 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 | |
| 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 | 00814639026757 [Primary] |
| GS1 | 10814639026754 [Package] Contains: 00814639026757 Package: box [12 Units] In Commercial Distribution |
| GAP | Suture, Nonabsorbable, Silk |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-30 |
| Device Publish Date | 2025-06-20 |
| 10814639026792 | Premium UNIFY Silk Sutures, 6-0, 13mm 3/8 circle Rev Cut, 18". Black. |
| 10814639026785 | Premium UNIFY Silk Sutures, 5-0, 13mm 3/8 circle Rev Cut, 18". Black. |
| 10814639026778 | Premium UNIFY Silk Sutures, 4-0, 13mm 3/8 circle Rev Cut, 18". Black. |
| 10814639026761 | Premium UNIFY Silk Sutures, 5-0, 19mm 3/8 circle Rev Cut, 18". Black. |
| 10814639026754 | Premium UNIFY Silk Sutures, 4-0, 19mm 3/8 circle Rev Cut, 18". Black. |
| 10814639026747 | Premium UNIFY Silk Sutures, 3-0, 19mm 3/8 circle Rev Cut, 18". Black. |