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Cartilage Microtome Module
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 990-004Model ENT Manual Reusable Surgical Instruments
Identity
- Trade Name
- CARTILAGE MICROTOME MODULE EUDAMEDFDA UDI
- Generic Name
- ENT cartilage cutter FDA UDI
- Device Name
- CARTILAGE MICROTOME MODULE FDA UDI
- Model / Reference
- 990-004 EUDAMEDFDA UDIENT Manual Reusable Surgical Instruments EUDAMED
- Description
- CARTILAGE MICROTOME MODULE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505009010 EUDAMEDFDA UDI
- Basic UDI-DI
- 08445050024LJ EUDAMED
- Direct Marketing DI
- 00844505009010 EUDAMED
- FDA Product Code
- FZT FDA UDI
- EMDN Code
- L149003 ENT RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- ENT cartilage cutter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: ENT cartilage cutter
Cartilage Microtome Module by Grace Medical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Grace Medical, Inc.
Sources (2)
- FDA UDI d95520d9-b536-422a-9261-95f118998a4e 34 fields · synced Jul 10, 2026
- EUDAMED b5c9c8fa-f3ff-46a0-a512-da74462d4e68 61 fields · synced Jul 10, 2026