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FlareHawk9 Gun Inserter Tray Insert
EUDAMEDFDA UDIClass I (EU MDR)
Ref ASY-01017
Identity
- Trade Name
- FlareHawk9 Gun Inserter Tray Insert EUDAMEDNA FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- FlareHawk Trays EUDAMEDFlareHawk9 Gun Inserter Tray Insert FDA UDI
- Model / Reference
- ASY-01017 EUDAMEDFDA UDI
- Description
- FlareHawk9 Gun Inserter Tray Insert FDA UDI
Identifiers
- Catalog Number
- ASY-01017 FDA UDI
- Primary DI / UDI-DI
- 00840200408554 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081000472FHTRAYSUH EUDAMED
- Direct Marketing DI
- 00840200408554 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
- 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
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
FlareHawk9 Gun Inserter Tray Insert 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 08c839f9-56a6-4f24-b629-d2f90f7e7e68 61 fields · synced Jun 17, 2026
- FDA UDI d56c4f79-ca3f-4360-8d66-11c67fa63702 35 fields · synced May 30, 2026