DeGen Standard Instrumentation
- Primary DI
- 00842048150251
- Brand
- DeGen Standard Instrumentation
- Company
- DEGEN MEDICAL, INC.
- Model
- 97-60M
- Catalog number
- 97-60M
- Device description
- Head Aligner, F1 MPS
- Published
- 2023-07-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Contact Domains#
degenmedical.comProduct Codes#
| Code | Name |
|---|---|
| LXH | Orthopedic manual surgical instrument |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00842048150251 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00842048150251 | 00842048150251 | 842048150251 | 0842048150251 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic implant/instrument assembling device | A non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(877)240-7838 | customerservice@degenmedical.com |
Regulatory Flags#
- DUNS number
- 078812602
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
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|---|---|---|---|---|
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| 00842048182733 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-161406L04 | 0306-161406L04 | 2025-11-24 |
| 00842048182740 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-161407L04 | 0306-161407L04 | 2025-11-24 |
| 00842048182757 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-161408L04 | 0306-161408L04 | 2025-11-24 |
| 00842048182764 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-161409L04 | 0306-161409L04 | 2025-11-24 |
| 00842048182771 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-161410L04 | 0306-161410L04 | 2025-11-24 |
| 00842048182788 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-161411L04 | 0306-161411L04 | 2025-11-24 |
| 00842048182795 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-161412L04 | 0306-161412L04 | 2025-11-24 |
| 00842048182801 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-161413L04 | 0306-161413L04 | 2025-11-24 |
| 00842048182818 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-161414L04 | 0306-161414L04 | 2025-11-24 |
| 00842048182979 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-181410L04 | 0306-181410L04 | 2025-11-24 |
| 00842048182986 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-181411L04 | 0306-181411L04 | 2025-11-24 |
| 00842048182993 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-181412L04 | 0306-181412L04 | 2025-11-24 |
| 00842048183006 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-181413L04 | 0306-181413L04 | 2025-11-24 |
| 00842048183013 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-181414L04 | 0306-181414L04 | 2025-11-24 |
| 00842048183327 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-121205L08 | 0306-121205L08 | 2025-11-24 |
| 00842048183334 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-121206L08 | 0306-121206L08 | 2025-11-24 |
| 00842048183341 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-121207L08 | 0306-121207L08 | 2025-11-24 |
| 00842048183358 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-121208L08 | 0306-121208L08 | 2025-11-24 |
| 00842048183365 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-121209L08 | 0306-121209L08 | 2025-11-24 |
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