| Primary Device ID | 00842048150398 |
| NIH Device Record Key | 55481d12-f8be-4abd-ab19-cf21348b19d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DeGen Standard Instrumentation |
| Version Model Number | 97-62D0716L |
| Catalog Number | 97-62D0716L |
| Company DUNS | 078812602 |
| Company Name | DEGEN MEDICAL, INC. |
| 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(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com | |
| Phone | +1(877)240-7838 |
| customerservice@degenmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842048150398 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
[00842048150398]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-24 |
| Device Publish Date | 2023-08-16 |
| 00842048154846 | Adapter W Spin Sleeve, 1/4 Square |
| 00842048154839 | Wire Cutter, 6 Inch |
| 00842048154822 | Guide Wire, Smooth, NiTi, 2.0mm, Long |
| 00842048154815 | Guide Wire, Smooth, NiTi, 2.0mm, Short |
| 00842048154808 | Guide Wire, Smooth, NiTi, 1.4mm, Long |
| 00842048154792 | Guide Wire, Smooth, NiTi, 1.4mm, Short |
| 00842048154785 | Guide Wire, Smooth, 316LVM, 2.0mm, Long |
| 00842048154778 | Guide Wire, Smooth, 316LVM, 2.0mm, Short |
| 00842048154761 | Guide Wire, Smooth, 316LVM, 1.4mm, Long |
| 00842048154754 | Guide Wire, Smooth, 316LVM, 1.4mm, Short |
| 00842048154747 | Adapter, Female Hex, 1/4 Drive |
| 00842048154730 | Adapter, Female Hex, A/O Drive |
| 00842048154723 | Adapter, Male Hex, 1/4 Drive |
| 00842048154716 | 7.5mm Solid tap |
| 00842048154709 | 6.5mm Solid tap |
| 00842048154693 | 5.5mm Solid tap |
| 00842048154686 | 4.5mm Solid tap |
| 00842048154679 | 4mm Hex Socket Driver |
| 00842048154662 | Self-Retaining Double Sided Driver, T30 |
| 00842048154655 | Cervical Plate Awl, 20mm |
| 00842048154648 | Cervical Plate Awl, 18mm |
| 00842048154631 | Cervical Plate Awl, 16mm |
| 00842048154624 | Cervical Plate Awl, 14mm |
| 00842048154617 | Cervical Plate Awl, 12mm |
| 00842048154600 | Cervical Plate Awl, 10mm |
| 00842048154594 | Axial Reducer |
| 00842048154587 | Dilator, 12.4mm Single Pass |
| 00842048154570 | Dilator, 12.4mm |
| 00842048154563 | Driver Assembly, Guarded |
| 00842048154556 | Dilator, 13mm |
| 00842048154549 | Ring, 45 |
| 00842048154532 | Ring, 15.7 |
| 00842048154525 | Screw Driver, Cannulated, T25 |
| 00842048154518 | Counter Torque, E3 Half Tab, RA |
| 00842048154501 | Driver Shaft Guard Assy |
| 00842048154495 | Sagittal Bender 5.5mm, Left |
| 00842048154488 | Sagittal Bender 5.5mm, Right |
| 00842048154471 | Self-Retaining Driver T30 Molded Handle |
| 00842048154464 | Anterior Cervical Distractor Forceps |
| 00842048154457 | Self-Retaining Driver, T30 |
| 00842048154440 | Sharp Wanding Blade Assembly |
| 00842048154433 | Head Positioner MIS Half Tab |
| 00842048154426 | Driver, T-30 Stab and Grab Modular |
| 00842048154419 | Screwdriver, Self Retaining Cervical, Solid Cap |
| 00842048154402 | Distractor Screw to Screw, Left |
| 00842048154396 | Distractor Screw to Screw, Right |
| 00842048154389 | Dilator Sleeve, Half Tab |
| 00842048154372 | Dilator Half Tab Head |
| 00842048154365 | Dilator, Large, Assembly |
| 00842048154358 | Power Driver, T15 |