Identity
- Trade Name
- BR Surgical, LLC FDA UDI
- Generic Name
- Vaginal speculum, reusable FDA UDI
- Device Name
- PEDERSON Long View Speculum, large, 70mm opening, 1" x 5 7/8" FDA UDI
- Model / Reference
- BR70-12603 FDA UDI
- Description
- PEDERSON Long View Speculum, large, 70mm opening, 1" x 5 7/8" FDA UDI
Identifiers
- Catalog Number
- BR70-12603 FDA UDI
- Primary DI / UDI-DI
- 00840183500405 FDA UDI
- FDA Product Code
- HDF FDA UDI
- GMDN Term
- Vaginal speculum, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4520 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal speculum, reusable
BR Surgical, LLC by Br Surgical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal speculum, reusable.
- Doyen hüvelylapoc, enyhén ívelt, 90x60 mm, 240 mm — SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság · Class I
- Non-Digital Vaginal Examination Duckbill Large Stainless Steel — Nadeem Surgical Corporation (Pvt.) Ltd. · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- ELMED — ELMED INCORPORATED · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- TEKNO-CER — TEKNO-CER CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Br Surgical Llc
Sources (1)
- FDA UDI 9f825b13-d6f8-405a-b178-7410f273c361 35 fields · synced May 30, 2026