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iSy® Disconnector
EUDAMEDFDA UDIClass I (EU MDR)
Ref P5300.6308
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Disconnector EUDAMEDiSy Abutment disconnector FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- iSy® General instruments EUDAMEDiSy Abutment disconnector, extra short FDA UDI
- Model / Reference
- P5300.6308 EUDAMEDFDA UDI
- Description
- iSy Abutment disconnector, extra short FDA UDI
Identifiers
- Catalog Number
- P5300.6308 FDA UDI
- Primary DI / UDI-DI
- 04099797021790 EUDAMEDE219P530063081 FDA UDI
- Basic UDI-DI
- 40997970008011000000000J5 EUDAMED
- Secondary DI
- E219P530063081 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
iSy® Disconnector by ALTATEC GmbH — 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 | 40997970008011000000000J5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED 5cd2d6ab-752e-40b4-a935-2f7f28b5c9ef 61 fields · synced Jul 27, 2026
- FDA UDI f5f000a4-2c52-434e-823f-8befcac98b91 35 fields · synced May 30, 2026