Identity
- Trade Name
- Variable Polarizing Hood FDA UDI
- Generic Name
- Multi-purpose digital medical camera lens, otoscopic FDA UDI
- Device Name
- An instrument that eliminates unwanted glare from surfaces that are being examined. FDA UDI
- Model / Reference
- GMD55100010 FDA UDI
- Description
- An instrument that eliminates unwanted glare from surfaces that are being examined. FDA UDI
Identifiers
- Catalog Number
- GMD55100010 FDA UDI
- Primary DI / UDI-DI
- 00850033167122 FDA UDI
- 510(k) Number
- K131338 FDA UDI
- FDA Product Code
- PEQ FDA UDI
- GMDN Term
- Multi-purpose digital medical camera lens, otoscopic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6320 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-purpose digital medical camera lens, otoscopic
Variable Polarizing Hood by GlobalMed Holdings, LLC — 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
- GlobalMed Holdings, LLC
Sources (1)
- FDA UDI 8c503a7a-5bfd-4f18-8b8e-4727779b4652 35 fields · synced Jun 9, 2026