| Primary Device ID | 10814639026563 |
| NIH Device Record Key | 3fb6a552-a869-462e-8e88-e55a9f4d2f67 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIFY Chromic Gut Surgical Sutures |
| Version Model Number | M-C318R19 |
| 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 | true |
| 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 | |
| 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 | 00814639026566 [Primary] |
| GS1 | 10814639026563 [Package] Contains: 00814639026566 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 |
| 1081463902131 | Chromic Gut, XL 2-0, 36mm 1/2 Cir Taper point, 27" |
| 10814639021308 | Chromic Gut, Sm 5-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639021292 | UNIFY Chromic Gut Surgical Sutures, XL 2-0, 36mm 1/2 Cir Taper point, 27" |
| 10814639021315 | Chromic Gut, XL 2-0, 36mm 1/2 Cir Taper point, 27" |
| 10814639026600 | Chromic Gut, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639026594 | UNIFY Chromic Gut Surgical Sutures, 5-0, 16mm 3/8 Cir Reverse Cut, 18". 12 pcs/box. |
| 10814639026587 | UNIFY Chromic Gut Surgical Sutures, 4-0, 16mm 3/8 Cir Reverse Cut, 18". 12 pcs/box. |
| 10814639026563 | UNIFY Chromic Gut Surgical Sutures, 3-0, 19mm 3/8 Cir Reverse Cut, 18". 12 pcs/box. |