Identity
- Trade Name
- Momentum FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- Guide wire, Ø 1.5mm, 500mm length, nitinol FDA UDI
- Model / Reference
- UU052-15-0500 FDA UDI
- Description
- Guide wire, Ø 1.5mm, 500mm length, nitinol FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814386024938 FDA UDI
- 510(k) Number
- K191932 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Orthopaedic guidewire, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic guidewire, single-use
Momentum by Ulrich Medical Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, single-use.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP. · Class II
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- 2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC · Class I
Cleared under the same submission
K191932 also covers:
- Momentum — ULRICH MEDICAL USA, INC.
- Momentum — ULRICH MEDICAL USA, INC.
- Momentum — ULRICH MEDICAL USA, INC.
- Momentum — ULRICH MEDICAL USA, INC.
- Momentum — ULRICH MEDICAL USA, INC.
- Momentum — ULRICH MEDICAL USA, INC.
- Momentum — ULRICH MEDICAL USA, INC.
- Momentum — ULRICH MEDICAL USA, INC.
- Momentum — ULRICH MEDICAL USA, INC.
- Momentum — ULRICH MEDICAL USA, INC.
- Momentum — ULRICH MEDICAL USA, INC.
- Momentum — ULRICH MEDICAL USA, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Ulrich Medical Usa, Inc.
Sources (1)
- FDA UDI 46d663a0-08a7-4430-ad81-d8017836122b 35 fields · synced May 30, 2026