Identity
- Trade Name
- ER-SPEC/OFFICE-SPEC FDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Device Name
- VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE LARGE - STERILE FDA UDI
- Model / Reference
- C020320 FDA UDI
- Description
- VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE LARGE - STERILE FDA UDI
Identifiers
- Catalog Number
- C020320 FDA UDI
- Primary DI / UDI-DI
- M648C0203200 FDA UDI
- 510(k) Number
- K091937 FDA UDI
- FDA Product Code
- HIB FDA UDI
- GMDN Term
- Vaginal speculum, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vaginal speculum, single-use
Er-Spec/Office-Spec by Obp Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal speculum, single-use.
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- AMSure® Disposable Vaginal Speculum — AMSINO INTERNATIONAL, INC. · Class II
- Centurion — Centurion Medical Products · Class II
- Vaginal Speculum — Dynarex Corp. · Class II
- Sklar — Sklar Corporation · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
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
- Obp Corporation
Sources (1)
- FDA UDI 1417c4dd-aa5d-42e9-ac44-f53ac1bd833e 36 fields · synced May 30, 2026