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Gendex GXC-300™ intraoral camera sheaths
FDA UDIClass I (US FDA UDI)
by Gendex Corp.
Identity
- Trade Name
- Gendex GXC-300™ intraoral camera sheaths FDA UDI
- Generic Name
- Cable/lead/sensor/probe cover, sterile FDA UDI
- Device Name
- 100 Count FDA UDI
- Model / Reference
- 0.822.2645 FDA UDI
- Description
- 100 Count FDA UDI
Identifiers
- Catalog Number
- 112 1347G2 FDA UDI
- Primary DI / UDI-DI
- EKAV082226450 FDA UDI
- FDA Product Code
- KQM FDA UDI
- GMDN Term
- Cable/lead/sensor/probe cover, sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Category: Cable/lead/sensor/probe cover, sterile
Gendex GXC-300™ intraoral camera sheaths by Gendex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Hygienic Sleeves Bite Block — CARESTREAM HEALTH, INC. · Class I
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
- Gendex Corp.
Sources (1)
- FDA UDI 46279ddd-b2ab-4439-8ddd-f5a83bbe76c1 36 fields · synced May 30, 2026