endophix
- Primary DI
- 06974940306635
- Company
- Suzhou Endophix Co., Ltd.
- Model
- MS-3208
- Published
- 2025-12-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Regulatory Flags
- DUNS number
- 620899345
- 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 |
|---|---|---|---|---|
| 06974940306635 | Primary | GS1 | 0 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|---|---|---|---|---|---|---|
| 06974940306635 | Primary | GS1 | 0 |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|---|---|---|---|---|---|
| HWJ | Awl | 1 | Orthopedic | 888.4540 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|---|
| Joint prosthesis implantation kit, reusable | A collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. 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.
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06974940306727 | endophix | MS-1525 | 2026-03-03 | |
| 06974940306758 | endophix | MS-1529 | 2026-03-03 | |
| 06974940306772 | endophix | MS-1535T | 2026-03-03 | |
| 06974940306857 | endophix | MS-1529-1 | 2026-03-03 | |
| 06974940306864 | endophix | MS-1529-2 | 2026-03-03 | |
| 06974940306918 | endophix | MS-1525-3 | 2026-03-03 | |
| 06974940307007 | endophix | MS-1529-3 | 2026-03-03 | |
| 06974940307021 | endophix | MS-1525-1 | 2026-03-03 | |
| 06974940307038 | endophix | MS-1525-2 | 2026-03-03 | |
| 06974940307045 | endophix | MS-430620S | 2025-12-19 | |
| 06974940307052 | endophix | MS-430820S | 2025-12-19 | |
| 06974940307069 | endophix | MS-430840S | 2025-12-19 | |
| 06974940307076 | endophix | MS-430860S | 2025-12-19 | |
| 06974940307083 | endophix | MS-431020S | 2025-12-19 | |
| 06974940307090 | endophix | MS-431050S | 2025-12-19 | |
| 06974940306321 | endophix | MS-3202 | 2025-12-12 | |
| 06974940306352 | endophix | MS-3203 | 2025-12-12 | |
| 06974940306369 | endophix | MS-3204 | 2025-12-12 | |
| 06974940306468 | endophix | MS-3205 | 2025-12-12 | |
| 06974940306604 | endophix | MS-3206 | 2025-12-12 |