| Primary Device ID | 10814639025955 |
| NIH Device Record Key | 3e787cad-eabe-445a-9124-2d9dba7a01bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium UNIFY Nylon Sutures |
| Version Model Number | PMN-427R19 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814639025958 [Primary] |
| GS1 | 10814639025955 [Package] Contains: 00814639025958 Package: bx [12 Units] In Commercial Distribution |
| GS1 | 20814639025952 [Package] Package: Case [100 Units] In Commercial Distribution |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-03 |
| Device Publish Date | 2023-06-23 |
| 20814639023729 | Premium UNIFY Nylon Sutures, LG 4-0, 24mm 3/8 circle Rev Cut, 27" |
| 20814639023712 | Premium UNIFY Nylon Sutures, LG 3-0, 24mm 3/8 circle Rev Cut, 27" |
| 20814639023705 | Premium UNIFY Nylon Sutures, LG 2-0, 24mm 3/8 circle Rev Cut, 27" |
| 20814639023583 | Premium UNIFY Nylon Sutures, Sm 6-0, 13mm 3/8 circle Rev Cut, 18", Undyed |
| 20814639023576 | Premium UNIFY Nylon Sutures, Sm 5-0, 13mm 3/8 circle Rev Cut, 18", Undyed |
| 20814639023569 | Premium UNIFY Nylon Sutures, Sm 4-0, 13mm 3/8 circle Rev Cut, 18", Undyed |
| 20814639023552 | Premium UNIFY Nylon Sutures, Med 5-0, 19mm 3/8 circle Rev Cut, 18", Undyed |
| 20814639023545 | Premium UNIFY Nylon Sutures, Med 5-0, 16mm 3/8 circle Rev Cut, 18", Undyed |
| 20814639023538 | Premium UNIFY Nylon Sutures, Med 4-0, 19mm 3/8 circle Rev Cut, 18", Undyed |
| 20814639023521 | Premium UNIFY Nylon Sutures, Med 4-0, 16mm 3/8 circle Rev Cut, 18", Undyed |
| 20814639023514 | Premium UNIFY Nylon Sutures, Medium 3-0, 19mm 3/8 circle Rev Cut, 18", Undyed |
| 20814639022845 | Premium UNIFY Nylon Sutures, Med 5-0, 16mm 3/8 circle Rev Cut, 18" |
| 20814639022838 | Premium UNIFY Nylon Sutures, Med 4-0, 16mm 3/8 circle Rev Cut, 18" |
| 10814639021483 | Premium UNIFY Nylon Sutures, Small 6-0, 13mm 3/8 circle Rev Cut, 18" |
| 10814639021476 | Premium UNIFY Nylon Sutures, Small 5-0, 13mm 3/8 circle Rev Cut, 18" |
| 10814639021469 | Premium UNIFY Nylon Sutures, Small 4-0, 13mm 3/8 circle Rev Cut, 18" |
| 10814639021452 | Premium UNIFY Nylon Sutures, Med 5-0, 19mm 3/8 circle Rev Cut, 18" |
| 10814639021445 | Premium UNIFY Nylon Sutures, Med 4-0, 19mm 3/8 circle Rev Cut, 18" |
| 10814639021438 | Premium UNIFY Nylon Sutures, 3-0, 19mm 3/8 circle Rev Cut, 18" |
| 10814639025955 | Premium UNIFY Nylon Sutures, 4-0, 19mm 3/8 circle Rev Cut, 27", Black. |
| 10814639025948 | Premium UNIFY Nylon Sutures, 3-0, 19mm 3/8 circle Rev Cut, 27", Black. |