Identity
- Trade Name
- Burr Hole Cover FDA UDI
- Generic Name
- Cranial bur hole cover FDA UDI
- Device Name
- The Burr Hole Cover package contains 1 Burr Hole Cover. FDA UDI
- Model / Reference
- 8110 FDA UDI
- Description
- The Burr Hole Cover package contains 1 Burr Hole Cover. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855547005205 FDA UDI
- FDA Product Code
- GXR FDA UDI
- GMDN Term
- Cranial bur hole cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 14 Millimeter FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customizedCranial bur hole cover
Burr Hole Cover by Neuropace, Inc. — 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
- Neuropace, Inc.
Sources (1)
- FDA UDI dbf4325a-4fb3-415d-a652-ede286b8a71a 36 fields · synced May 30, 2026