Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- Surgical Instrument EUDAMEDKOGAN ENDOSPECULA WITH RATCHET, 3 X 23 MM LENGTH 280 MM FDA UDI
- Model / Reference
- GU.1333.03 EUDAMEDFDA UDI
- Description
- KOGAN ENDOSPECULA WITH RATCHET, 3 X 23 MM LENGTH 280 MM FDA UDI
Identifiers
- Catalog Number
- GU.1333.03 FDA UDI
- Primary DI / UDI-DI
- 04049047046875 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047LBR03ANA27DROR6 EUDAMED
- Direct Marketing DI
- 04049047046875 EUDAMED
- FDA Product Code
- HDF FDA UDI
- EMDN Code
- L059001 VAGINAL SPECULUMS, REUSABLE EUDAMED
- GMDN Term
- Self-retaining surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.4520 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: Self-retaining surgical retractor, reusable
Gimmi by Gimmi GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Self-retaining surgical retractor, reusable.
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Symmetry Cloward — SYMMETRY SURGICAL INC. · Class II
- Life Instruments — Life Instrument Corporation · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SELF RETAINING CORONOID RETRACTOR CHAIN WITH RINGS — W.H. Holden, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (2)
- FDA UDI 2c03ae57-e7d3-471e-aa17-4e7aee01b9b5 35 fields · synced Jun 11, 2026
- EUDAMED e7c6107c-b091-4580-9c80-f16ef51e5694 61 fields · synced Jun 11, 2026