Identity
- Trade Name
- ANOSPEC FDA UDI
- Generic Name
- Optical anoscope, single-use FDA UDI
- Device Name
- 103x18mm SINGLE-USE BEVELED ANOSCOPE WITH BUILT-IN LIGHT SOURCE FDA UDI
- Model / Reference
- C060120 FDA UDI
- Description
- 103x18mm SINGLE-USE BEVELED ANOSCOPE WITH BUILT-IN LIGHT SOURCE FDA UDI
Identifiers
- Catalog Number
- C060120 FDA UDI
- Primary DI / UDI-DI
- M648C0601200 FDA UDI
- 510(k) Number
- K121604 FDA UDI
- FDA Product Code
- FER FDA UDI
- GMDN Term
- Optical anoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Optical anoscope, single-use
Anospec by Obp Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Optical anoscope, single-use.
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- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope — THD SPA · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope — THD SPA · Class II
- THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope — THD SPA · Class II
Cleared under the same submission
K121604 also covers:
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 81b7dfbc-ba84-4722-b88e-eb34fda15135 36 fields · synced Jun 1, 2026