Identity
- Trade Name
- Spiral Drill FDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- Spiral Drill, Cannulated, D=3.2mm/D=1.7mm, L=100mm FDA UDI
- Model / Reference
- 61322-100 FDA UDI
- Description
- Spiral Drill, Cannulated, D=3.2mm/D=1.7mm, L=100mm FDA UDI
Identifiers
- Catalog Number
- 61322-100 FDA UDI
- Primary DI / UDI-DI
- 09120047301166 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Cannulated 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Cannulated surgical drill bit, reusable
Spiral Drill by I.T.S. GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cannulated surgical drill bit, reusable.
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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
- I.T.S. GmbH
Sources (1)
- FDA UDI 72b54176-939f-4ab8-a5b6-829a9ece0153 34 fields · synced Jun 8, 2026