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Instrument Kit: Abutment Screw Adjustment G
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2715
by Integrum AB
Identity
- Trade Name
- Instrument Kit: Abutment Screw Adjustment G EUDAMEDInstrument Kit: Abutment Screw Adjustment G FDA UDI
- Generic Name
- Internal-external leg prosthesis osseointegration bar FDA UDI
- Device Name
- OPRA Implant System Instruments - OPRA Instrument Kits EUDAMEDSurgical Instrument Kit for Abutment Screw adjustment. FDA UDI
- Model / Reference
- 2715 EUDAMEDFDA UDI
- Description
- Surgical Instrument Kit for Abutment Screw adjustment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07340152102386 EUDAMEDFDA UDI
- Basic UDI-DI
- 73401521RUinstrumentkit4A EUDAMED
- Direct Marketing DI
- 07340152102386 EUDAMED
- PMA Number
- P190009 FDA UDI
- FDA Product Code
- PJY FDA UDI
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Internal-external leg prosthesis osseointegration bar FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- Sweden 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Instrument Kit: Abutment Screw Adjustment G by Integrum AB — 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 | 73401521RUinstrumentkit4A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Integrum AB
- EUDAMED SRN
- SE-MF-000026900
Sources (2)
- EUDAMED 0919d017-7838-45af-b4ef-fbe1ca79658f 61 fields · synced Oct 1, 2026
- FDA UDI c054bbe4-4d4c-4858-b6f9-3580076931e6 34 fields · synced May 30, 2026