Identity
- Trade Name
- BEAR FDA UDI
- Generic Name
- Rigid optical sinoscope FDA UDI
- Device Name
- Rigid ENT Endoscope, 4.0 x 185mm, 30 Deg. FDA UDI
- Model / Reference
- BV4030 FDA UDI
- Description
- Rigid ENT Endoscope, 4.0 x 185mm, 30 Deg. FDA UDI
Identifiers
- Catalog Number
- BV4030 FDA UDI
- Primary DI / UDI-DI
- G043BV40300 FDA UDI
- 510(k) Number
- K981751 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Rigid optical sinoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid optical sinoscope
Bear by Bear-Ent, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical sinoscope.
- JEDMED — JEDMED Instrument Company · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- SINUSCOPE — Ecleris · Class II
- JEDMED — JEDMED Instrument Company · Class II
- JEDMED — JEDMED Instrument Company · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- PrimeSight — SCHÖLLY FIBEROPTIC GmbH · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
Cleared under the same submission
K981751 also covers:
- BEAR — Bear-Ent, LLC
- BEAR — Bear-Ent, LLC
- BEAR — Bear-Ent, LLC
- BEAR — Bear-Ent, LLC
- BEAR — Bear-Ent, LLC
- BEAR — Bear-Ent, LLC
- BEAR — Bear-Ent, LLC
- BEAR — Bear-Ent, LLC
- BEAR — Bear-Ent, LLC
- BEAR — Bear-Ent, LLC
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bear-Ent, LLC
Sources (1)
- FDA UDI c84f2356-1ac6-419d-bf89-d861d9181785 35 fields · synced Jun 8, 2026