Identity
- Trade Name
- Anoscope FDA UDI
- Generic Name
- Optical anoscope, single-use FDA UDI
- Device Name
- Self-Light Diagnostic Proctoscope FDA UDI
- Model / Reference
- A.4019 FDA UDI
- Description
- Self-Light Diagnostic Proctoscope FDA UDI
Identifiers
- Catalog Number
- A.4019 FDA UDI
- Primary DI / UDI-DI
- 08033638800027 FDA UDI
- 510(k) Number
- K070913 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
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: Optical anoscope, single-use
Anoscope by Sapi Med Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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
- ANOSPEC — OBP CORPORATION · 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
Cleared under the same submission
K070913 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
- Sapi Med Spa
Sources (1)
- FDA UDI 3b817d38-2a9d-44cb-b059-05398ce11741 35 fields · synced Jun 1, 2026