Identity
- Trade Name
- Bite Block FDA UDI
- Generic Name
- Endoscopic bite block, basic, single-use FDA UDI
- Device Name
- Bite Block FDA UDI
- Model / Reference
- 92808 FDA UDI
- Description
- Bite Block FDA UDI
Identifiers
- Catalog Number
- 69100 FDA UDI
- Primary DI / UDI-DI
- 00350770928081 FDA UDI
- 510(k) Number
- K830781 FDA UDI
- FDA Product Code
- FOG FDA UDI
- GMDN Term
- Endoscopic bite block, basic, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5700 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic bite block, basic, single-use
Bite Block by Avanos Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic bite block, basic, single-use.
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- E-Z Guard — US Endoscopy · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Breathe-EZ — Micro-tech Usa · Class I
- Breathe-EZ — Micro-tech Usa · Class I
Cleared under the same submission
K830781 also covers:
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
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 48055a8e-987d-45de-a33a-b82fa64ffbfe 36 fields · synced Jun 9, 2026