| Primary Device ID | 10814639023906 |
| NIH Device Record Key | d7172733-77c9-48be-b5d1-2ceb94513f83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium UNIFY PGLA Sutures |
| Version Model Number | PXXLU-G027T40 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814639023909 [Primary] |
| GS1 | 10814639023906 [Package] Contains: 00814639023909 Package: box [12 Units] In Commercial Distribution |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-15 |
| Device Publish Date | 2018-08-13 |
| 10814639023920 | Premium PGLA Suture, Size 2/0, 40mm 1/2 Cir Taper Point, Undyed, 27" |
| 10814639023913 | Premium PGLA Suture, Size 2/0, 40mm 1/2 Cir Taper Point, Violet, 27" |
| 10814639023906 | Premium PGLA Suture, Size 0, 40mm 1/2 Cir Taper Point, Undyed, 27" |
| 10814639023890 | Premium PGLA Suture, Size 0, 40mm 1/2 Cir Taper Point, Violet, 27" |
| 10814639023883 | Premium PGLA Suture, Size 1, 40mm 1/2 Cir Taper Point, Undyed. 27" |
| 20814639023804 | Premium PGLA, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18" Violet. |
| 20814639023798 | Premium PGLA, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18" Undyed. |
| 20814639023781 | Premium PGLA Suture, Size 4-0, 24mm 3/8 Cir Rev Cut, Violet, 27" |
| 20814639023767 | Premium PGLA Suture, Size 3-0, 24mm 3/8 Cir Rev Cut, Violet, 27" |