Identity
- Trade Name
- Helix Locking Tool FDA UDI
- Generic Name
- Torque manipulation device FDA UDI
- Device Name
- Helix Locking Tool EUDAMED
- Model / Reference
- 5616 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810024670307 EUDAMED00810024670291 FDA UDI
- Basic UDI-DI
- 081002467leaddevaccesVA EUDAMED
- Unit of Use DI
- 10810024670304 EUDAMED
- FDA Product Code
- DWS FDA UDI
- EMDN Code
- C0280 ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Torque manipulation device FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Market of Registration
- Netherlands 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Helix Locking Tool by CenterPoint Systems LLC — 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081002467leaddevaccesVA | Class I | Active |
| EUDAMED | European Union | CE/MDR | 081002467leaddevaccesVA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CenterPoint Systems LLC
- EUDAMED SRN
- US-MF-000009054
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED bbdb9ca6-c01e-4914-beba-3d33f7b96ca2 61 fields · synced Jun 9, 2026
- FDA UDI d7691b62-5a4f-46a6-b702-9d2445c42e2c 33 fields · synced May 30, 2026