Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Self-retaining ear speculum FDA UDI
- Device Name
- Surgical Instrument EUDAMEDHARTMANN EAR SPECULA FIG. 3, STAINLESS STEEL Ø 4.5 MM FDA UDI
- Model / Reference
- QO.1003.05 EUDAMEDFDA UDI
- Description
- HARTMANN EAR SPECULA FIG. 3, STAINLESS STEEL Ø 4.5 MM FDA UDI
Identifiers
- Catalog Number
- QO.1003.05 FDA UDI
- Primary DI / UDI-DI
- 04049047075318 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047LDR03ANA27DROTG EUDAMED
- Direct Marketing DI
- 04049047075318 EUDAMED
- FDA Product Code
- EPY FDA UDI
- EMDN Code
- L149004 ENT SPECULUMS, REUSABLE EUDAMED
- GMDN Term
- Self-retaining ear speculum FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.1800 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 ear speculum
Gimmi by Gimmi GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Self-retaining ear speculum.
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- Ambler Surgical — Ambler Surgical, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · 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 5ed2d0bb-6c29-4f7d-9bc6-c75b80c72e06 35 fields · synced Jul 31, 2026
- EUDAMED 29f87efe-3daf-403e-9be3-6b98ed2b4cb2 61 fields · synced Jul 31, 2026