Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Fixed-diameter cervical dilator, reusable FDA UDI
- Device Name
- Surgical Instrument EUDAMEDHEGAR UTERINE DILATOR WITH SLOPED HANDLE Ø 20 MM FDA UDI
- Model / Reference
- GV.1403.20 EUDAMEDFDA UDI
- Description
- HEGAR UTERINE DILATOR WITH SLOPED HANDLE Ø 20 MM FDA UDI
Identifiers
- Catalog Number
- GV.1403.20 FDA UDI
- Primary DI / UDI-DI
- 04049047047193 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047LGJ03ANA27DROP7 EUDAMED
- Direct Marketing DI
- 04049047047193 EUDAMED
- FDA Product Code
- HDQ FDA UDI
- EMDN Code
- L0509020199 GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fixed-diameter cervical dilator, reusable 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: Fixed-diameter cervical dilator, reusable
Gimmi by Gimmi GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-diameter cervical dilator, reusable.
- Surgical — TIMESCO HEALTHCARE LIMITED · Class I
- Hegar méhnyak tágító, enyhén kúpos heggyel, d= 3 mm, 180 mm — SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság · Class I
- Kleegman Stainless Steel Dilator — MEDGYN PRODUCTS, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Galabins méhszonda, d= 3, 6 mm, 295 mm — SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- AESCULAP — AESCULAP, INC. · 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 c89cc2ce-836a-40c1-9b9e-e506a752e985 35 fields · synced Jul 9, 2026
- EUDAMED d06adc44-523b-4046-a05c-4d74d875f221 61 fields · synced Jul 9, 2026