Identity
- Trade Name
- AccuShape FDA UDI
- Generic Name
- Cranioplasty plate, non-alterable FDA UDI
- Device Name
- PEEK CRANIAL IMPLANT & MODELS BUNDLE FDA UDI
- Model / Reference
- ZB-SPK100 FDA UDI
- Description
- PEEK CRANIAL IMPLANT & MODELS BUNDLE FDA UDI
Identifiers
- Catalog Number
- ZB-SPK100 FDA UDI
- Primary DI / UDI-DI
- 00810007631684 FDA UDI
- FDA Product Code
- GXN FDA UDILLZ FDA UDI
- GMDN Term
- Cranioplasty plate, non-alterable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5330 FDA UDI892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Cranioplasty plate, non-alterableCustom-made organ/bone anatomy model
AccuShape by Medcad — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medcad
Sources (1)
- FDA UDI 42e4060e-53b4-41c4-be0f-7e04798ffacd 35 fields · synced May 30, 2026