Identity
- Trade Name
- Hallu®- LOCK FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- The right plate bender is used to bend the Hallu® Lock C plate in combination with the left plate bender in order to match the degree of dorsal flexion required by the case or by the activity of the patient. FDA UDI
- Model / Reference
- 299080ND FDA UDI
- Description
- The right plate bender is used to bend the Hallu® Lock C plate in combination with the left plate bender in order to match the degree of dorsal flexion required by the case or by the activity of the patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780052029 FDA UDI
- FDA Product Code
- HXW FDA UDI
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Manual orthopaedic bender, reusable
Hallu®- LOCK by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI 8f5d4375-25f7-4e3a-b980-a302ec86f26a 35 fields · synced Jun 1, 2026