Identity
- Trade Name
- Brasseler EZX FDA UDI
- Generic Name
- Sawing power tool attachment, sagittal FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- BREZG101 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800038055544 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Sawing power tool attachment, sagittal FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Brasseler EZX by Imedicom Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Imedicom Co., Ltd.
Sources (1)
- FDA UDI e3b33064-4e1e-4d39-8b70-2734a1e80979 34 fields · synced Jun 8, 2026