Tecomet
- Primary DI
- 00841435124912
- Company
- TECOMET INC.
- Model
- AR-9938-11
- Device description
- Wire Cutter
- Published
- 2025-09-05
- 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
Regulatory Flags
- DUNS number
- 078749695
- 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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00841435124912 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00841435124912 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| HXZ | Cutter, Wire | 1 | Orthopedic | 888.4540 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic implantable-device cutter | A heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device. |
Device Sizes
No records found.
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
No records found.
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|---|
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| D90980001641 | ORTHO ARCH | Ortho Arch Company Inc | HXZ | 2025-09-15 |
| D90980001651 | ORTHO ARCH | Ortho Arch Company Inc | HXZ | 2025-09-15 |
| D9098000331 | SPECTRUM | Ortho Arch Company Inc | HXZ | 2025-09-15 |
| D90980021311 | RAZOR | Ortho Arch Company Inc | HXZ | 2025-09-15 |
| D90980021412 | RAZOR | Ortho Arch Company Inc | HXZ | 2025-09-15 |
| D90980021513 | RAZOR | Ortho Arch Company Inc | HXZ | 2025-09-15 |
| D90980021715 | RAZOR | Ortho Arch Company Inc | HXZ | 2025-09-15 |
| D90980021816 | RAZOR | Ortho Arch Company Inc | HXZ | 2025-09-15 |
| D90980021917 | RAZOR | Ortho Arch Company Inc | HXZ | 2025-09-15 |
| D90980022312 | RAZOR | Ortho Arch Company Inc | HXZ | 2025-09-15 |
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