| Primary Device ID | 20814639023620 |
| NIH Device Record Key | f0bede2f-bb55-43aa-9442-cc98932ca381 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIFY PTFE Surgical Sutures |
| Version Model Number | M-F318R19 |
| Catalog Number | M-F318R19 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814639023626 [Primary] |
| GS1 | 10814639023623 [Package] Contains: 00814639023626 Package: Box [12 Units] In Commercial Distribution |
| GS1 | 20814639023620 [Package] Contains: 10814639023623 Package: Case [100 Units] In Commercial Distribution |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| 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 | 2017-09-30 |
| 20814639023699 | PTFE Sutures, Non-absorbable, 6-0, monofilament, 13mm 3/8 circle Rev Cut, 18" |
| 20814639023682 | PTFE Sutures, Non-absorbable, 5-0, monofilament, 13mm 3/8 circle Rev Cut, 18" |
| 20814639023675 | PTFE Sutures, Non-absorbable, 4-0, monofilament, 13mm 1/2 circle Taper Point, 18" |
| 20814639023668 | PTFE Sutures, Non-absorbable, 4-0, monofilament, 13mm 3/8 circle Rev Cut, 18" |
| 20814639023651 | PTFE Sutures, Non-absorbable, 4-0, monofilament, 19mm 3/8 circle Rev Cut, 18" |
| 20814639023644 | PTFE Sutures, Non-absorbable, 4-0, monofilament, 16mm 3/8 circle Rev Cut, 18" |
| 20814639023637 | PTFE Sutures, Non-absorbable, 3-0, monofilament, 16mm 3/8 circle Rev Cut, 18" |
| 20814639023620 | PTFE Sutures, Non-absorbable, 3-0, monofilament, 19mm 3/8 circle Rev Cut, 18" |
| 00814639023619 | PTFE Sutures, Non-absorbable, 2-0, monofilament, 19mm 3/8 circle Rev Cut, 18" |
| 10814639024859 | PTFE Sutures, Non-absorbable, 3-0, monofilament, 50mm straight needle, 30" |
| 10814639024842 | PTFE Sutures, Non-absorbable, 2-0, monofilament, 60mm straight needle, 30" |
| 10814639024057 | PTFE Sutures, Non-absorbable, 2-0, monofilament, 36mm 1/2 circle Taper point, 30" |
| 10814639022237 | PTFE Sutures, Non-absorbable, 5-0, monofilament, 16mm 3/8 circle Rev Cut, 18" |