FDA UDI
In Commercial Distribution
🇺🇸 United States
iFix®
DI: M543CM1612
·
Model: CM-1612
·
CAYENNE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- iFix®
- Primary DI
- M543CM1612
- Version / Model
- CM-1612
- Catalog Number
- CM-1612
- Company Name
- CAYENNE MEDICAL, INC.
- Labeler DUNS
- 606719685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-29
- Public Version
- 3
- Public Version Date
- 2025-05-30
- Public Version Status
- Update
- Public Device Record Key
- 01bcfaf9-2737-490a-8230-a50232e78cb9
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWT | Template | Orthopedic | 888.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56649 | Tendon/ligament graft preparation station | An assembly of devices designed to provide the operator with a workstation for the preparation and pretensioning of a ligament and/or tendon graft prior to implantation. It typically consists of a work base to provide a stable platform on which the graft can be treated, various types of adjustable and fixed posts including soft tissue clamps and tensioning devices, a graft sizing block, and tools to hold and tension a graft (e.g., an Allen key). It may be used for a variety of bone-tendon-bone and soft tissue grafts such as semitendinosus patellar tendon, quadriceps tendon, or patellar tendon grafts for anterior cruciate ligament (ACL) reconstruction. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M543CM1612 | HIBCC |