| Primary Device ID | 10814639024262 |
| NIH Device Record Key | 5b810e29-3a25-41f9-838f-72b9a645605a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIFY PDO Surgical Sutures |
| Version Model Number | L-D330R24-U |
| 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 | |
| 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 | |
| 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 | 00814639024265 [Primary] |
| GS1 | 10814639024262 [Package] Contains: 00814639024265 Package: Box [12 Units] In Commercial Distribution |
| GS1 | 20814639024269 [Package] Package: Carton [100 Units] In Commercial Distribution |
| NEW | Suture, Surgical, Absorbable, Polydioxanone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-12 |
| Device Publish Date | 2020-08-04 |
| 20814639022524 | UNIFY PDO Surgical Sutures, Absorbable, 5-0, 16mm 3/8 Circle Rev Cut, 18" |
| 20814639022517 | UNIFY PDO Surgical Sutures, Absorbable, 4-0, 16mm 3/8 Circle Rev Cut, 18" |
| 10814639020882 | UNIFY PDO Surgical Sutures, Absorbable, XXL 1, 40mm 3/8 Circle Rev Cut, 30" |
| 10814639020875 | UNIFY PDO Surgical Sutures, Absorbable, XL 2-0, 36mm 1/2 Circle Taper Pt, 30" |
| 10814639020868 | UNIFY PDO Surgical Sutures, Absorbable, XL 0, 36mm 1/2 Circle Taper Pt, 30" |
| 10814639020851 | UNIFY PDO Surgical Sutures, Absorbable, XL 0, 30mm 3/8 Circle Rev Cut, 30" |
| 10814639020844 | UNIFY PDO Surgical Sutures, absorbable, 6-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639020837 | UNIFY PDO Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639020820 | UNIFY PDO Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639020813 | UNIFY PDO Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639020806 | UNIFY PDO Surgical Sutures, Absorbable, 4-0, 17mm 1/2 Circle Taper Point, 30" |
| 10814639020790 | UNIFY PDO Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 30" |
| 10814639020783 | UNIFY PDO Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639020776 | UNIFY PDO Surgical Sutures, Absorbable, 3-0, 17mm 1/2 Circle Taper Point, 30" |
| 10814639020769 | UNIFY PDO Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 30" |
| 10814639020752 | UNIFY PDO Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639020745 | UNIFY PDO Surgical Sutures, Absorbable, 3-0, 26mm 1/2 Circle Taper Pt, 30" |
| 10814639020738 | UNIFY PDO Surgical Sutures, Absorbable, LG 3-0, 24mm 3/8 Circle Rev Cut, 30" |
| 10814639020721 | UNIFY PDO Surgical Sutures, Absorbable, LG 2-0, 26mm 1/2 Circle Taper Pt, 30" |
| 10814639020714 | UNIFY PDO Surgical Sutures, Absorbable, LG 2-0, 24mm 3/8 Circle Rev Cut, 30" |
| 10814639024316 | UNIFY PDO Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18" Undyed |
| 10814639024309 | UNIFY PDO Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18" Undyed |
| 10814639024293 | UNIFY PDO Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed |
| 10814639024286 | UNIFY PDO Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 18" Undyed |
| 10814639024279 | UNIFY PDO Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18" Undyed |
| 10814639024262 | UNIFY PDO Surgical Sutures, Absorbable, LG 3-0, 24mm 3/8 Circle Rev Cut, 30" Undyed |
| 10814639024255 | UNIFY PDO Surgical Sutures, Absorbable, 3-0, 26mm 1/2 Circle Taper Pt, 30" Undyed |
| 10814639024248 | UNIFY PDO Surgical Sutures, Absorbable, LG 2-0, 24mm 3/8 Circle Rev Cut, 30" Undyed |
| 10814639024231 | UNIFY PDO Surgical Sutures, Absorbable, XL 2-0, 36mm 1/2 Circle Taper Pt, 30" Undyed |
| 10814639024118 | UNIFY PDO Surgical Sutures, Absorbable, XXL Size 2, 40mm 3/8 Circle Rev Cut, 30" |
| 10814639025917 | UNIFY PDO Surgical Sutures, Absorbable, LG 3-0, 24mm 3/8 Circle Rev Cut, 30" 3 Dzn. |
| 10814639025900 | UNIFY PDO Surgical Sutures, Absorbable, LG 2-0, 24mm 3/8 Circle Rev Cut, 30" 3 DZN |
| 10814639026129 | UNIFY PDO Surgical Sutures, Absorbable, 2-0, 19mm 3/8 Circle Rev Cut, 30" |