Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Uterine probe FDA UDI
- Device Name
- Surgical Instrument EUDAMEDSIMS UTERINE SOUND; RIGID, GRADUATED IN CM; LENGTH 320 MM FDA UDI
- Model / Reference
- GQ.1586.32 EUDAMEDFDA UDI
- Description
- SIMS UTERINE SOUND; RIGID, GRADUATED IN CM; LENGTH 320 MM FDA UDI
Identifiers
- Catalog Number
- GQ.1586.32 FDA UDI
- Primary DI / UDI-DI
- 04049047045243 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047LUP03ANA27DRODA EUDAMED
- Direct Marketing DI
- 04049047045243 EUDAMED
- FDA Product Code
- HHM FDA UDI
- EMDN Code
- L05090501 UTERINE SURGICAL PROBES, REUSABLE EUDAMED
- GMDN Term
- Uterine probe FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.4530 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: Uterine probe
Gimmi by Gimmi GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Uterine probe.
- GEN2 — SURGIX MEDICAL LLC · Class II
- Quinelato — Schobell Industrial Ltda · Class I
- American Medicals — AMERICAN MEDICALS · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- GEN2 — SURGIX MEDICAL LLC · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Vaginal Probe — CooperSurgical, Inc. · Class I
- V. Mueller — STERIS CORPORATION · 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 0717b6ea-c66b-416c-812e-407488d6bfcd 35 fields · synced Jul 11, 2026
- EUDAMED e432e7dd-beb4-4ca1-b905-cb30bcc74530 61 fields · synced Jul 11, 2026