| Primary Device ID | 1081463902131 |
| NIH Device Record Key | 32eada71-093a-4d0d-aad6-34a74cd01a8d |
| Commercial Distribution Discontinuation | 2018-05-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | UNIFY Chromic Gut Surgical Sutures |
| Version Model Number | XL-C227T36 |
| Company DUNS | 017524666 |
| Company Name | APPLIED DENTAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does n |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814639021318 [Primary] |
| GS1 | 1081463902131 [Package] Contains: 00814639021318 Package: box [12 Units] Discontinued: 2018-05-21 Not in Commercial Distribution |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2015-08-21 |
| 1081463902131 | Chromic Gut, XL 2-0, 36mm 1/2 Cir Taper point, 27" |
| 10814639021308 | Chromic Gut, Sm 5-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639021292 | UNIFY Chromic Gut Surgical Sutures, XL 2-0, 36mm 1/2 Cir Taper point, 27" |
| 10814639021315 | Chromic Gut, XL 2-0, 36mm 1/2 Cir Taper point, 27" |
| 10814639026600 | Chromic Gut, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18" |
| 10814639026594 | UNIFY Chromic Gut Surgical Sutures, 5-0, 16mm 3/8 Cir Reverse Cut, 18". 12 pcs/box. |
| 10814639026587 | UNIFY Chromic Gut Surgical Sutures, 4-0, 16mm 3/8 Cir Reverse Cut, 18". 12 pcs/box. |
| 10814639026563 | UNIFY Chromic Gut Surgical Sutures, 3-0, 19mm 3/8 Cir Reverse Cut, 18". 12 pcs/box. |