| Primary Device ID | 10814639026730 |
| NIH Device Record Key | 4b2f60cb-d4fd-4ca4-906b-f00713959c90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIFY Polyester Surgical Sutures |
| Version Model Number | L-E230R26 |
| 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 | 00814639026733 [Primary] |
| GS1 | 10814639026730 [Package] Contains: 00814639026733 Package: box [12 Units] In Commercial Distribution |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 |
| 10814639021209 | UNIFY Polyester Surgical Sutures, XXL 1, 40mm 3/8 circle Rev Cut, 30" |
| 10814639021193 | UNIFY Polyester Surgical Sutures, XL 0, 30mm 3/8 circle Rev Cut, 30" |
| 10814639021186 | UNIFY Polyester Surgical Sutures, Small 6-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639021179 | UNIFY Polyester Surgical Sutures, Small 5-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639021162 | UNIFY Polyester Surgical Sutures, Med 4-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639021155 | UNIFY Polyester Surgical Sutures, Med 3-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639021148 | UNIFY Polyester Surgical Sutures, LG 2-0, 24mm 3/8 Circle Rev Cut, 30" |
| 10814639026815 | UNIFY Polyester Surgical Sutures, LG 3-0, 24mm 3/8 Circle Rev Cut, 30" |
| 10814639026808 | UNIFY Polyester Surgical Sutures, 4-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639026730 | UNIFY Polyester Surgical Sutures, LG 2-0, 26mm 3/8 Circle Rev Cut, 30" |