Identity
- Trade Name
- LTV FDA UDI
- Generic Name
- Total wrist prosthesis FDA UDI
- Device Name
- Exhalation Valve W/O PEEP, Reusable FDA UDI
- Model / Reference
- 18172-001 FDA UDI
- Description
- Exhalation Valve W/O PEEP, Reusable FDA UDI
Identifiers
- Catalog Number
- 18172-001 FDA UDI
- Primary DI / UDI-DI
- 10190752185241 FDA UDI
- 510(k) Number
- K101643 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Total wrist prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Category: Total wrist prosthesis
Ltv by Vyaire Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total wrist prosthesis.
- Universal2 Total Wrist Implant System — Smith & Nephew, Inc. · Class II
- Freedom Wrist Arthroplasty System — Smith & Nephew, Inc. · Class II
- Universal2 Total Wrist Implant System — Smith & Nephew, Inc. · Class II
- Universal 2™ Total Wrist System — Ascension Orthopedics, Inc. · Class II
- KinematX — Extremity Medical, LLC · Class II
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc. · Class II
- Freedom Wrist Arthroplasty System — Smith & Nephew, Inc. · Class II
- Integra® Freedom Wrist Arthroplasty System — Ascension Orthopedics, Inc. · Class II
Cleared under the same submission
K101643 also covers:
- LTV — VYAIRE MEDICAL, INC.
- LTV — VYAIRE MEDICAL, INC.
- LTV — VYAIRE MEDICAL, INC.
- LTV — VYAIRE MEDICAL, INC.
- LTV — VYAIRE MEDICAL, INC.
- LTV — VYAIRE MEDICAL, INC.
- LTV — VYAIRE MEDICAL, INC.
- LTV — VYAIRE MEDICAL, INC.
- LTV — VYAIRE MEDICAL, INC.
- LTV — VYAIRE MEDICAL, INC.
- LTV — VYAIRE MEDICAL, INC.
- LTV — VYAIRE MEDICAL, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vyaire Medical, Inc.
Sources (1)
- FDA UDI 5bf97a2f-9a96-48fd-8587-73245b2ff570 36 fields · synced May 30, 2026