Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Ring cutter FDA UDI
- Device Name
- Surgical Instrument EUDAMEDSAW BLADE FOR KV.1978.17 FDA UDI
- Model / Reference
- KV.1979.01 EUDAMEDFDA UDI
- Description
- SAW BLADE FOR KV.1978.17 FDA UDI
Identifiers
- Catalog Number
- KV.1979.01 FDA UDI
- Primary DI / UDI-DI
- 04049047064107 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047LAE03ANA27DROBE EUDAMED
- Direct Marketing DI
- 04049047064107 EUDAMED
- FDA Product Code
- FNS FDA UDI
- EMDN Code
- L010702 BLADES FOR MANUAL SURGICAL SAWS, REUSABLE EUDAMED
- GMDN Term
- Ring cutter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6200 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: Ring cutter
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 Ring cutter.
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- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, 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 d55d0a12-cd43-483a-967e-29ddd4964ecd 35 fields · synced Jun 19, 2026
- EUDAMED 467e09d5-1473-4240-b659-c8f0fd5afe52 61 fields · synced Jun 19, 2026