Identity
- Trade Name
- MC-Subtalar™ II FDA UDI
- Generic Name
- Subtalar implant, non-bioabsorbable FDA UDI
- Model / Reference
- 6 25 T20 FDA UDI
Identifiers
- Catalog Number
- FH39256S FDA UDI
- Primary DI / UDI-DI
- 04048266162960 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Subtalar implant, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 25 Millimeter FDA UDIOuter Diameter — 6 Millimeter FDA UDI
MC-Subtalar™ II by Merete GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Merete GmbH
Sources (1)
- FDA UDI 9ae876ad-5ef1-47c4-97a4-ed1726852d7d 36 fields · synced Jun 1, 2026