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MIS Disc Prep Set Tray Insert - Bottom
EUDAMEDFDA UDIClass I (EU MDR)
Ref ASY-00527
Identity
- Trade Name
- MIS Disc Prep Set Tray Insert - Bottom EUDAMEDN/A FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- FlareHawk Trays EUDAMEDMIS Disc Prep Set Tray Insert-Bottom FDA UDI
- Model / Reference
- ASY-00527 EUDAMEDFDA UDI
- Description
- MIS Disc Prep Set Tray Insert-Bottom FDA UDI
Identifiers
- Catalog Number
- ASY-00527 FDA UDI
- Primary DI / UDI-DI
- 00810004729292 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081000472FHTRAYSUH EUDAMED
- Direct Marketing DI
- 00810004729292 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
MIS Disc Prep Set Tray Insert - Bottom by Integrity Implants Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0081000472FHTRAYSUH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Integrity Implants Inc.
- EUDAMED SRN
- US-MF-000009805
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED ebe0ad53-2067-4a83-9b74-925e55acae6b 61 fields · synced Jul 29, 2026
- FDA UDI 9299b263-1ce5-4936-94a0-eba97884dd8a 35 fields · synced May 30, 2026