Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Mouth gag, adjustable, reusable FDA UDI
- Device Name
- Surgical Instrument EUDAMEDJENNINGS MOUTH GAG 150 MM FDA UDI
- Model / Reference
- QT.0405.15 EUDAMEDFDA UDI
- Description
- JENNINGS MOUTH GAG 150 MM FDA UDI
Identifiers
- Catalog Number
- QT.0405.15 FDA UDI
- Primary DI / UDI-DI
- 04049047373551 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047LGY03ANA27DRO5T EUDAMED
- Direct Marketing DI
- 04049047373551 EUDAMED
- FDA Product Code
- KBN FDA UDI
- EMDN Code
- L14010299 OROPHARYNGAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Mouth gag, adjustable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 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: Mouth gag, adjustable, reusable
Gimmi by Gimmi GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mouth gag, adjustable, reusable.
- FENTEX — FENTEX medical GmbH · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Integra® — Integra LifeSciences Production Corporation · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Reicodent — devemed GmbH · 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 2b3c5b57-1c09-4fc1-9234-d9072ed877ea 35 fields · synced Jul 26, 2026
- EUDAMED 3fe971da-d797-4da4-9888-bc182d7ee579 61 fields · synced Jul 26, 2026