Identity
- Trade Name
- KaWe FDA UDI
- Generic Name
- Ear speculum, reusable FDA UDI
- Device Name
- 2.5mm Reusable Specula for KaWe COMBILIGHT® FDA UDI
- Model / Reference
- 61-847-010 FDA UDI
- Description
- 2.5mm Reusable Specula for KaWe COMBILIGHT® FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845821020833 FDA UDI
- FDA Product Code
- FXG FDA UDI
- GMDN Term
- Ear speculum, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.1800 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ear speculum, reusable
KaWe by Medical, Inc. — 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
- Medical, Inc.
Sources (1)
- FDA UDI 8e53d566-fecf-4fe0-985b-ddb38efcf2a3 34 fields · synced May 30, 2026