Identity
- Trade Name
- LARGE QWIX® FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- The internal protection sleeve 1 for 5.5mm screws is used during bone drilling to insert K-wire and protect the soft tissues. This internal protection sleeve 1 shall be inserted within the drilling guide 2 referenced 119152ND, itself inserted within the external protection sleeve referenced 119153ND. FDA UDI
- Model / Reference
- 119151ND FDA UDI
- Description
- The internal protection sleeve 1 for 5.5mm screws is used during bone drilling to insert K-wire and protect the soft tissues. This internal protection sleeve 1 shall be inserted within the drilling guide 2 referenced 119152ND, itself inserted within the external protection sleeve referenced 119153ND. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780042877 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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: Surgical drill guide, reusable
Large Qwix® by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
- Titan™ — Ascension Orthopedics, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI 7b0978f1-611f-4451-bd52-87a616b343dd 36 fields · synced Jun 1, 2026