Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Sphincteroscope FDA UDI
- Device Name
- Surgical Instrument EUDAMEDKELLY PROCTOSCOPE FIG. 1 Ø 22 MM X 50 MM FDA UDI
- Model / Reference
- PU.1678.01 EUDAMEDFDA UDI
- Description
- KELLY PROCTOSCOPE FIG. 1 Ø 22 MM X 50 MM FDA UDI
Identifiers
- Catalog Number
- PU.1678.01 FDA UDI
- Primary DI / UDI-DI
- 04049047074793 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047ZCD03ANA27DROWP EUDAMED
- Direct Marketing DI
- 04049047074793 EUDAMED
- FDA Product Code
- FFO FDA UDI
- EMDN Code
- Z12020603 PROCTOSCOPES EUDAMED
- GMDN Term
- Sphincteroscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Sphincteroscope
Gimmi by Gimmi GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Sphincteroscope.
- Surgical Instrument — GIMMI GMBH · Class I
- THD M-PROCTO (TR/NS) — THD S.P.A. · Class I
- THD LIGHT-SCOPE HRA LASER — THD S.P.A. · Class I
- THD L-PROCTO (BE/NS) — THD S.P.A. · Class I
- THD M-PROCTO (NE/NS) — THD S.P.A. · Class I
- THD L-PROCTO (TR/NS) — THD S.P.A. · Class I
- proctoscopes — HILBRO INSTRUMENTS (PVT) LTD · Class I
- Surgical Instrument — GIMMI GMBH · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (2)
- FDA UDI 69604e75-0e1d-4c18-9f53-10f5e7bcab8b 35 fields · synced Aug 3, 2026
- EUDAMED c9a0992b-bc56-40fb-9560-5a4b25d20b71 61 fields · synced Aug 3, 2026