Identity
- Trade Name
- Perforator Motor FDA UDI
- Generic Name
- Manual cranial rotary handpiece, reusable FDA UDI
- Model / Reference
- 362641 FDA UDI
Identifiers
- Catalog Number
- 1601133-001 FDA UDI
- Primary DI / UDI-DI
- 07630055507860 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Manual cranial rotary handpiece, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual cranial rotary handpiece, reusable
Perforator Motor by Bien-Air Surgery SA — 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
- Bien-Air Surgery SA
Sources (1)
- FDA UDI 6a7f8dc9-39cf-4b6f-98ec-baa6bb272851 33 fields · synced May 30, 2026