| Primary Device ID | 10814639022794 |
| NIH Device Record Key | 8c353de0-c85c-455c-816d-91de06916fad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium UNIFY Chromic Sutures |
| Version Model Number | PMC-518R16 |
| 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 | 00814639022797 [Primary] |
| GS1 | 10814639022794 [Package] Contains: 00814639022797 Package: box [12 Units] In Commercial Distribution |
| GS1 | 20814639022791 [Package] Package: case [100 Units] In Commercial Distribution |
| GAL | Suture, Absorbable, Natural |
| 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 | 2016-09-23 |
| 10814639022916 | Premium UNIFY Plain Gut Sutures Med 4-0, 19mm 3/8 Circle Rev Cut, 27" |
| 10814639022909 | Premium UNIFY Chromic Sutures Med 4-0, 19mm 3/8 Circle Rev Cut, 27" |
| 10814639022794 | Premium UNIFY Chromic Sutures Med 5-0, 16mm 3/8 Circle Rev Cut, 18" |
| 10814639022787 | Premium UNIFY Chromic Sutures Med 4-0, 16mm 3/8 Circle Rev Cut, 18" |
| 10814639022770 | Premium UNIFY Plain Gut Sutures Med 5-0, 16mm 3/8 Circle Rev Cut, 18" |
| 10814639022763 | Premium UNIFY Plain Gut Sutures Med 4-0, 16mm 3/8 Circle Rev Cut, 18" |
| 10814639022459 | Premium UNIFY Chromic Sutures, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639022442 | Premium UNIFY Chromic Sutures Med 3-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639021384 | Premium UNIFY Chromic Sutures, Sm 5-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639021377 | Premium UNIFY Chromic Sutures, Sm 4-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639021360 | Premium UNIFY Chromic Sutures Med 4-0, 19mm 3/8 Circle Rev Cut, 18" |
| 10814639021353 | Premium UNIFY Chromic Sutures, Med 3-0, 19mm 3/8 Circle Rev Cut, 27" |
| 10814639021346 | Premium UNIFY Chromic Sutures, LG 2-0, 26mm 1/2 Cir Taper point, 27" |
| 10814639021339 | Premium UNIFY Chromic Sutures, XL 2-0, 36mm 1/2 Cir Taper point, 27" |
| 10814639021322 | Premium UNIFY Chromic Sutures, LG 2-0, 24mm 3/8 Circle Rev Cut, 27" |
| 10814639024828 | Premium UNIFY Chromic Sutures, LG 3-0, 24mm 3/8 Circle Rev Cut, 27" |