Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Fixed-diameter cervical dilator, reusable FDA UDI
- Device Name
- Surgical Instrument EUDAMEDHAWKIN AMBLER UTERINE DILATOR Ø 11.0 / 14.0 MM FDA UDI
- Model / Reference
- GV.1443.11 EUDAMEDFDA UDI
- Description
- HAWKIN AMBLER UTERINE DILATOR Ø 11.0 / 14.0 MM FDA UDI
Identifiers
- Catalog Number
- GV.1443.11 FDA UDI
- Primary DI / UDI-DI
- 04049047702764 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047LGJ03ANA27DROP7 EUDAMED
- Direct Marketing DI
- 04049047702764 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Fixed-diameter cervical dilator, reusable
The Gimmi device is a highly effective and versatile obstetric medical instrument designed to facilitate safe and efficient dilation of the cervix, making it an essential tool for healthcare professionals in various clinical settings.
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
MDR
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 0bbaa4c0-d65e-4432-9925-56bae4508623 35 fields · synced Jul 30, 2026
- EUDAMED 0c811c97-f5b3-4196-8428-a28c40b736f9 61 fields · synced Jul 30, 2026