| Primary Device ID | 10814639020677 |
| NIH Device Record Key | 1443c65c-5931-4a08-84cf-6dc86a1fac67 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIFY Silk Surgical Sutures |
| Version Model Number | S-S618R13 |
| 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 | 00814639020670 [Primary] |
| GS1 | 10814639020677 [Package] Contains: 00814639020670 Package: Box [12 Units] In Commercial Distribution |
| GS1 | 20814639020674 [Package] Package: case [100 Units] In Commercial Distribution |
| GAP | Suture, Nonabsorbable, Silk |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-08-19 |
| 20814639023163 | UNIFY Silk Sutures, XXL 2-0/30", 60mm Straight Cutting |
| 20814639023132 | UNIFY Silk Sutures, XXL 3-0/30", 60mm Straight Cutting |
| 20814639022647 | Silk, Med 5-0, 16mm 3/8 Circle Rev Cut, 18" |
| 20814639022630 | Silk, Med 4-0, 16mm 3/8 Circle Rev Cut, 18" |
| 10814639020677 | Silk, Small 6-0 13mm 3/8 Circle Rev Cut, 18" |
| 10814639020660 | Silk, Small 5-0 13mm 3/8 Circle Rev Cut, 18" |
| 10814639020653 | Silk, Small 4-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639020646 | Silk, Med 5-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639020639 | Silk, Med 4-0/30", 19mm 3/8 Circle Rev Cut |
| 10814639020622 | Silk, Med 4-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639020615 | Silk, Med 3-0/30", 19mm 3/8 Circle Rev Cut |
| 10814639020608 | Silk, Med 3-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639020295 | UNIFY Silk Surgical Sutures, XXL 1, 40mm 3/8 circle Rev Cut, 30" |