| Primary Device ID | 10814639026495 |
| NIH Device Record Key | a9406c9e-6003-47b8-858d-d350bbb460ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium UNIFY Fast Plain Gut Sutures |
| Version Model Number | PSRJ-618R13 |
| Catalog Number | PSRJ-618R13 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814639026498 [Primary] |
| GS1 | 10814639026495 [Package] Contains: 00814639026498 Package: bx [12 Units] In Commercial Distribution |
| GS1 | 20814639026492 [Package] Package: Case [100 Units] In Commercial Distribution |
| GAL | Suture, Absorbable, Natural |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-25 |
| Device Publish Date | 2024-10-17 |
| 10814639026488 | Premium UNIFY Fast Plain Gut Sutures, Small 5-0, 13mm 3/8 Circle Conventional Cut, 18" |
| 10814639026211 | Premium UNIFY Fast Plain Gut Sutures, Small 5-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639026495 | Premium UNIFY Fast Absorbing Gut Sutures, Small 6-0, 13mm 3/8 Circle Rev Cut, 18" |