Identity
- Trade Name
- BR Surgical, LLC FDA UDI
- Generic Name
- Rigid optical hysteroscope FDA UDI
- Device Name
- Hysteroscope, autoclavable, Ø 4mm, 0º, 302mm FDA UDI
- Model / Reference
- BR970-4000-302 FDA UDI
- Description
- Hysteroscope, autoclavable, Ø 4mm, 0º, 302mm FDA UDI
Identifiers
- Catalog Number
- BR970-4000-302 FDA UDI
- Primary DI / UDI-DI
- 00857556008338 FDA UDI
- FDA Product Code
- HIH FDA UDIFAJ FDA UDI
- GMDN Term
- Rigid optical hysteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI876.1500 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
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 hysteroscope
BR Surgical, LLC by Br Surgical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical hysteroscope.
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- MyoSure XL Rod Lens Hysteroscope — Hologic, Inc. · Class II
- Hysteroscope — SOPRO-COMEG GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Gimmi — Gimmi GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
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 |
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Manufacturer
- Manufacturer
- Br Surgical Llc
Sources (1)
- FDA UDI a4ed8d4a-dc44-4e75-9744-28dd2dd6828f 35 fields · synced Jun 8, 2026