| Primary Device ID | 10886705013715 |
| NIH Device Record Key | f47128cb-aa27-4e5d-8440-2593783ba928 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 254728 |
| Catalog Number | 254728 |
| Company DUNS | 190572854 |
| Company Name | DEPUY MITEK, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886705013715 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
[10886705013715]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-09-18 |
| Device Publish Date | 2015-09-01 |
| 20886705002174 - PANACRYL | 2024-06-03 Rotator Cuff EasyAnchor with PANACRYL Size 2 (5 metric) PANACRYL braided absorbable suture, 36 Inches (91 cm), double-armed with |
| 10886705008292 - FASTIN PANACRYL | 2024-06-03 FASTIN RC Anchor with PANACRYL Titanium Anchor with two Number 2 PANACRYL Poly (L-Lactide/Glycolide) Braided Absorbable Sutures, |
| 10886705009374 - VAPR | 2024-06-03 VAPR LD Suction Electrode 4 mm x 160 mm |
| 10886705009381 - VAPR | 2024-06-03 VAPR LP Suction Electrode 4 mm x 160 mm |
| 10886705000913 - NA | 2024-05-30 Rotator Cuff Anchor Threader Tab |
| 10886705001064 - LUPINE ORTHOCORD | 2024-05-30 LUPINE Loop Plus Anchor w/ORTHOCORD Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD Braided Composite Sut |
| 10886705001071 - LUPINE ORTHOCORD | 2024-05-30 LUPINE Loop PLUS Dual Suture (DS) Anchor w/ORTHOCORD PLA Absorbable Anchor, with two size 2 (5 metric) ORTHOCORD braided composi |
| 10886705002412 - QUICKANCHOR PANACRYL | 2024-05-30 MINILOK QUICKANCHOR Plus (Number 2/0) Suture Poly (L-lactide) absorbable anchor, size 2/0 PANACRYL braided absorbable suture (3 |