Identity
- Trade Name
- SPE-Instrument PERLA ® FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- FIXED DRILL L12 FDA UDI
- Model / Reference
- SPE-US FD 12-N FDA UDI
- Description
- FIXED DRILL L12 FDA UDI
Identifiers
- Catalog Number
- SPE-US FD 12-N FDA UDI
- Primary DI / UDI-DI
- 07640185348295 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.4 Millimeter FDA UDILength — 12 Millimeter FDA UDI
Category: Fluted surgical drill bit, reusable
SPE-Instrument PERLA ® by Spineart — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Spineart
Sources (1)
- FDA UDI 6447ba96-1dce-4d61-8cf5-bd46cc3a5808 35 fields · synced May 31, 2026