Identity
- Trade Name
- Holding sleeve EUDAMEDHolding sleeve for screw implants FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- Holding sleeve for screw implants EUDAMEDHolding sleeve for screw implants, Ø 4.3 mm FDA UDI
- Model / Reference
- J5302.4300 EUDAMEDFDA UDI
- Description
- Holding sleeve for screw implants, Ø 4.3 mm FDA UDI
Identifiers
- Catalog Number
- J5302.4300 FDA UDI
- Primary DI / UDI-DI
- 04099797012873 EUDAMEDE219J530243001 FDA UDI
- Basic UDI-DI
- 40997970008004000000000KV EUDAMED
- Secondary DI
- E219J530243001 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic implantation sleeve, 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
Holding sleeve 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 | 40997970008004000000000KV | 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 0e1e37b7-d1ec-428b-bcb2-100fc26eaf49 61 fields · synced Jul 20, 2026
- FDA UDI 648422a1-1f1d-475b-a3a9-376ee5b92ac7 35 fields · synced May 29, 2026