| 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 | |
| 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 | |
| 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
[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
[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 |
| 10886705007516 - FASTIN ETHIBOND | 2025-12-16 FASTIN ANCHOR Size 2 (5 metric) green ETHIBOND braided polyester suture, 26 Inches (66cm), Anchor 5.2mm Diameter x 11.5mm long. |
| 20886705000903 - NA | 2025-09-29 SuperAnchor Threader Tab |
| 10886705000951 - NA | 2025-09-29 SuperAnchor Threader Tab |
| 10886705001088 - LUPINE ETHIBOND | 2025-09-29 LUPINE Loop PLUS Anchor w/ETHIBOND PLA Absorbable Anchor, size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches ( |
| 10886705001958 - QUICKANCHOR PANACRYL | 2025-09-29 Rotator Cuff QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), with CP-2 needles, with dis |
| 10886705001989 - GII QUICKANCHOR PANACRYL | 2025-09-29 GII QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), double armed with CP-2 needles, with |
| 10886705001996 - QUICKANCHOR PANACRYL | 2025-09-29 Super QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), double armed with CP-2 needles, wi |
| 10886705002047 - ETHIBOND | 2025-09-29 Rotator Cuff EasyAnchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), with disposable inserter |