| Primary Device ID | 10814639026662 |
| NIH Device Record Key | 0fcfa3f9-6023-4fab-a04c-80fe15e4d525 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIFY Plain Gut Sutures |
| Version Model Number | M-J430R19 |
| Catalog Number | M-J430R19 |
| 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 | true |
| Manufacturing Date | false |
| 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 | 00814639026665 [Primary] |
| GS1 | 10814639026662 [Package] Contains: 00814639026665 Package: box [12 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 | 2025-06-27 |
| Device Publish Date | 2025-06-19 |
| 10814639021247 | UNIFY Plain Gut Sutures, Small 5-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639021230 | UNIFY Plain Gut Sutures, Small 4-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639021223 | UNIFY Plain Gut Sutures |
| 10814639021216 | UNIFY Plain Gut Sutures Med 3-0, 19mm 3/8 Circle Rev Cut, 27" |
| 10814639026693 | UNIFY Plain Gut Sutures, 5-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639026679 | UNIFY Plain Gut Sutures, 5-0, 16mm 3/8 Circle Rev Cut, 18" |
| 10814639026662 | UNIFY Plain Gut Sutures Med 4-0, 19mm 3/8 Circle Rev Cut, 30" |
| 10814639026655 | UNIFY Plain Gut Sutures, 4-0, 16mm 3/8 Circle Rev Cut, 18" |
| 10814639026648 | UNIFY Plain Gut Sutures, 3-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639026617 | UNIFY Plain Gut Sutures, Small 6-0, 13mm 3/8 Circle Rev Cut, 18" |