Identity
- Trade Name
- IEC-Innoview GmbH FDA UDI
- Generic Name
- Otoscope, endoscopic FDA UDI
- Device Name
- 4.0 mm, 0 deg. Otoscope, l=50mm, autoclavable FDA UDI
- Model / Reference
- 30-0043-00 FDA UDI
- Description
- 4.0 mm, 0 deg. Otoscope, l=50mm, autoclavable FDA UDI
Identifiers
- Catalog Number
- 30-0043-00 FDA UDI
- Primary DI / UDI-DI
- B192300043000 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Otoscope, endoscopic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 50 Millimeter FDA UDIOuter Diameter — 4.0 Millimeter FDA UDIAngle — 0 degree FDA UDI
Category: Otoscope, endoscopic
IEC-Innoview GmbH by Innovative Endoscopy Components, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Otoscope, endoscopic.
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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
- Innovative Endoscopy Components, L.l.c.
Sources (1)
- FDA UDI f23825b7-d8cc-4947-aef4-8f4892554c86 35 fields · synced Jun 1, 2026