Hyper-C
- Primary DI
- 00842048152194
- Brand
- Hyper-C
- Company
- DEGEN MEDICAL, INC.
- Model
- 02-13G16
- Catalog number
- 02-13G16
- Device description
- Drill Bit, Long, 16mm
- Published
- 2022-08-22
- 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 |
|---|---|---|---|---|
| 00842048152194 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00842048152194 | 00842048152194 | 842048152194 | 0842048152194 |
GMDN Terms#
| Term | Definition |
|---|---|
| Cannulated surgical drill bit, single-use, non-sterile | A non-sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use 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#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00842048182726 | Latitude-C AM™ Cervical Interbody Fusion System | 0306-161405L04 | 0306-161405L04 | 2025-11-24 |
| 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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