| Primary Device ID | 20814639022630 | 
| NIH Device Record Key | 17477d37-cf27-47f4-8afc-839b46f499ba | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | UNIFY Silk Surgical Sutures | 
| Version Model Number | M-S418R16 | 
| 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 | 00814639022636 [Primary] | 
| GS1 | 10814639022633 [Package] Contains: 00814639022636 Package: box [12 Units] In Commercial Distribution | 
| GS1 | 20814639022630 [Package] Contains: 10814639022633 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 | 3 | 
| Public Version Date | 2018-07-06 | 
| Device Publish Date | 2016-11-09 | 
| 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" |