FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Collagen Meniscus Implant CMI®
DI: M92843001
·
Model: Medial 7.5 mm
·
IVY SPORTS MEDICINE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Collagen Meniscus Implant CMI®
- Primary DI
- M92843001
- Version / Model
- Medial 7.5 mm
- Catalog Number
- 4300
- Company Name
- IVY SPORTS MEDICINE LLC
- Labeler DUNS
- 046226406
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 5
- Public Version Date
- 2021-11-23
- Public Version Status
- Update
- Public Device Record Key
- a7bc39b0-2c6c-4a1b-a1dd-417c69398574
- Distribution End Date
- 2018-08-31
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OLC | Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59099 | Meniscus biomatrix implant, animal-derived | A bioabsorbable animal-derived material intended to be implanted to fill a defect in a damaged meniscus for the reinforcement of the remaining meniscus, and to provide a porous scaffold (matrix) intended to be replaced by natural tissue. It is made of an animal-derived material (e.g., bovine or porcine collagen) and is implanted during a minimally-invasive arthroscopic surgical procedure after trimming to fit the measured defect; it is available in a variety of sizes. This device is not intended to replace the entire meniscus. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M92843001 | HIBCC |
Customer Contacts
- Phone
- 1-800-624-4422
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Medial 7.5 mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius