Identity
- Trade Name
- Sani-Scope FDA UDI
- Generic Name
- Optical anoscope, single-use FDA UDI
- Device Name
- Sani-Scope® Disposable Anoscope FDA UDI
- Model / Reference
- 82420 FDA UDI
- Description
- Sani-Scope® Disposable Anoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50888937013653 FDA UDI
- 510(k) Number
- K841909 FDA UDI
- FDA Product Code
- HIB FDA UDI
- GMDN Term
- Optical anoscope, 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Optical anoscope, single-use
Sani-Scope by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Optical anoscope, single-use.
- THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope — THD SPA · Class II
- HEINE UniSpec® Disposable Tubes — Heine Optotechnik GmbH & Co. KG · 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
- 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
K841909 also covers:
- Galenica — CooperSurgical, Inc.
- Galenica — CooperSurgical, Inc.
- Galenica — CooperSurgical, Inc.
- Galenica — CooperSurgical, Inc.
- Galenica — CooperSurgical, Inc.
- Galenica — CooperSurgical, Inc.
- Sani-Spec — CooperSurgical, Inc.
- Sani-Spec — CooperSurgical, Inc.
- Sani-Spec — CooperSurgical, Inc.
- Sani-Spec — CooperSurgical, Inc.
- Sani-Spec — CooperSurgical, Inc.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 7258bdf2-d4c0-4933-a5d0-3f84c70ed23a 34 fields · synced Jun 9, 2026