Identity
- Trade Name
- TotalExam® Oto 2.0 FDA UDI
- Generic Name
- Multi-purpose digital medical camera FDA UDI
- Device Name
- TotalExam® Oto 2.0, Otoscope Camera FDA UDI
- Model / Reference
- GMD5505HD22 FDA UDI
- Description
- TotalExam® Oto 2.0, Otoscope Camera FDA UDI
Identifiers
- Catalog Number
- GMD5505HD22 FDA UDI
- Primary DI / UDI-DI
- 00850033167030 FDA UDI
- FDA Product Code
- KZF FDA UDI
- GMDN Term
- Multi-purpose digital medical camera 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-purpose digital medical camera
TotalExam® Oto 2.0 by GlobalMed Holdings, LLC — 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
- GlobalMed Holdings, LLC
Sources (1)
- FDA UDI d9ac6b47-cdf6-4ef6-8cc0-37d9b22f5767 35 fields · synced Jun 9, 2026