Identity
- Trade Name
- Hallu®- LOCK FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Device Name
- The 14mm phalangeal yellow colored reamer is used to ream the articular surface of the phalanx for maximal contact and ultimate snug-fit of bone ends. Its shape creates a concave cup-shaped phalangeal surface to receive the convex shaped metatarsal surface. It must be used with the same color coded metatarsal reamer to have the same diameter of bone ends. FDA UDI
- Model / Reference
- 129724ND FDA UDI
- Description
- The 14mm phalangeal yellow colored reamer is used to ream the articular surface of the phalanx for maximal contact and ultimate snug-fit of bone ends. Its shape creates a concave cup-shaped phalangeal surface to receive the convex shaped metatarsal surface. It must be used with the same color coded metatarsal reamer to have the same diameter of bone ends. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780044956 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, 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: Bone-resection orthopaedic reamer, 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 bbfda507-54c8-457f-bb23-ef8fa9d13a54 36 fields · synced May 31, 2026