Identity
- Trade Name
- CANNULATED PEDIGUARD FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Model / Reference
- CANNULATED PEDIGUARD HANDLE FDA UDI
Identifiers
- Catalog Number
- P2HE1000 FDA UDI
- Primary DI / UDI-DI
- 03662674000068 FDA UDI
- 510(k) Number
- K143159 FDA UDI
- FDA Product Code
- ETN FDA UDIPDQ FDA UDI
- GMDN Term
- Bone access cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone access cannula
Cannulated Pediguard by Spineguard — 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
- Spineguard
Sources (1)
- FDA UDI 3579613a-0fcf-4993-b0dc-f3068b53d493 36 fields · synced May 30, 2026