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Grafys Delivering Gun
EUDAMEDFDA UDIClass I (EU MDR)
Ref GYINJECTSModel Orthopaedic cement dispensing gun
by Graftys
Identity
- Trade Name
- GRAFYS DELIVERING GUN EUDAMEDGRAFTYS® DELIVERING GUN FDA UDI
- Generic Name
- Orthopaedic cement dispenser FDA UDI
- Device Name
- GRAFTYS Delivering Gun EUDAMEDGRAFTYS DELIVERY GUN FDA UDI
- Model / Reference
- Orthopaedic cement dispensing gun EUDAMEDGYINJECTS EUDAMEDFDA UDI
- Description
- GRAFTYS DELIVERY GUN FDA UDI
Identifiers
- Catalog Number
- GYINJECTS FDA UDI
- Primary DI / UDI-DI
- 03760177571327 EUDAMED03760177571655 FDA UDI
- Basic UDI-DI
- B-03760177571327 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED
- GMDN Term
- Orthopaedic cement dispenser FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Grafys Delivering Gun by Graftys — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760177571327 | Class I | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Graftys
- EUDAMED SRN
- FR-MF-000019838
Sources (2)
- EUDAMED 5dcd14b6-8277-47b2-8d62-9dfedd1bbfa6 61 fields · synced Jul 16, 2026
- FDA UDI 2b591f75-dff4-4948-83ea-e52c2b29ccba 34 fields · synced May 30, 2026