Identity
- Trade Name
- SPECULUM FDA UDI
- Generic Name
- Vaginal speculum, reusable FDA UDI
- Device Name
- SPECULUM - STANDARD 4-1/2" LENGTH FDA UDI
- Model / Reference
- H57 FDA UDI
- Description
- SPECULUM - STANDARD 4-1/2" LENGTH FDA UDI
Identifiers
- Catalog Number
- H57 FDA UDI
- Primary DI / UDI-DI
- 00841494104672 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
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: Vaginal speculum, reusable
Speculum by Cynosure, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal speculum, reusable.
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- 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
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
- Cynosure, LLC
Sources (1)
- FDA UDI 0682e1e5-0e51-4b40-85cc-7a5ea1009c5e 34 fields · synced Jun 1, 2026