Identity
- Trade Name
- Bioplate® FDA UDI
- Generic Name
- Cranioplasty plate, non-alterable FDA UDI
- Device Name
- 5-Tab Zip Implant - 16 mm FDA UDI
- Model / Reference
- 81-3595[US] FDA UDI
- Description
- 5-Tab Zip Implant - 16 mm FDA UDI
Identifiers
- Catalog Number
- 81-3595[US] FDA UDI
- Primary DI / UDI-DI
- M384813595US0 FDA UDI
- 510(k) Number
- K070901 FDA UDI
- FDA Product Code
- GXN FDA UDI
- GMDN Term
- Cranioplasty plate, non-alterable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5330 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 16 Millimeter FDA UDI
Bioplate® by Bioplate, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioplate, Inc.
Sources (1)
- FDA UDI e4b9c94c-64e6-48db-ba4f-7d9273530dcd 38 fields · synced May 31, 2026