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Cartilage MACROTOME Tissue Support
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 990-106Model ENT Manual Reusable Surgical Instruments
Identity
- Trade Name
- CARTILAGE MACROTOME TISSUE SUPPORT DIAL EUDAMEDCartilage MACROTOME Tissue Support FDA UDI
- Generic Name
- ENT cartilage cutter FDA UDI
- Device Name
- Cartilage MACROTOME Tissue Support, For Use With Cartilage MACROTOME, Stainless Steel FDA UDI
- Model / Reference
- 990-106 EUDAMEDFDA UDIENT Manual Reusable Surgical Instruments EUDAMED
- Description
- Cartilage MACROTOME Tissue Support, For Use With Cartilage MACROTOME, Stainless Steel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505012522 EUDAMEDFDA UDI
- Basic UDI-DI
- 08445050024LJ EUDAMED
- Direct Marketing DI
- 00844505012522 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 MACROTOME Tissue Support 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Grace Medical, Inc.
Sources (2)
- FDA UDI 9df7ae15-fca6-49f6-842c-111b34ba4ef9 34 fields · synced Jul 16, 2026
- EUDAMED 4f0ff359-2440-471f-a722-1c5976c8648a 61 fields · synced Jul 16, 2026