| Primary Device ID | 10814639024415 |
| NIH Device Record Key | a1a37f5d-977e-4504-9622-415952caab0f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium UNIFY RPGA Surgical Sutures |
| Version Model Number | PMK-518R19 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814639024418 [Primary] |
| GS1 | 10814639024415 [Package] Contains: 00814639024418 Package: Box [12 Units] In Commercial Distribution |
| GS1 | 20814639024412 [Package] Package: Carton [100 Units] In Commercial Distribution |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| 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 |
| 10814639024835 | Premium UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 24mm 3/8 Circle Rev Cut, 27". Undyed |
| 10814639024439 | Premium UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18". Undyed |
| 10814639024422 | Premium UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18". Undyed |
| 10814639024415 | Premium UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18". Undyed |
| 10814639024408 | Premium UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 27". Undyed |
| 10814639024392 | Premium UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 18". Undyed |
| 10814639024385 | Premium UNIFY RPGA Surgical Sutures, Absorbable, 3-0, 24mm 3/8 Circle Rev Cut, 27". Undyed |
| 10814639024378 | Premium UNIFY RPGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18". Undyed |
| 00814639024364 | Premium UNIFY RPGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 27". Undyed |