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Retractor
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref A.4081LModel Proctoscope
by Sapi Med Spa
Identity
- Trade Name
- TRUNK-END ANAL RETRACTOR + LED LIGHT EUDAMEDRetractor FDA UDI
- Generic Name
- Optical anoscope, single-use FDA UDI
- Device Name
- Anal retractor FDA UDI
- Model / Reference
- Proctoscope EUDAMEDA.4081L EUDAMEDA.4081 FDA UDI
- Description
- Anal retractor FDA UDI
Identifiers
- Catalog Number
- A.4081 FDA UDI
- Primary DI / UDI-DI
- 08033638800089 EUDAMEDFDA UDI
- Basic UDI-DI
- 803363880ANSCPB6 EUDAMED
- 510(k) Number
- K070913 FDA UDI
- FDA Product Code
- FER FDA UDI
- EMDN Code
- G02060301 ANOSCOPES EUDAMED
- GMDN Term
- Optical anoscope, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Retractor by Sapi Med Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K070913 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sapi Med Spa
Sources (2)
- FDA UDI c1539f8d-4a58-4d56-8801-1aa1bfac7f0d 35 fields · synced Jul 17, 2026
- EUDAMED 2e813abf-e445-43f2-86a5-746be7d0dc14 61 fields · synced Jul 17, 2026