Identity
- Trade Name
- Tornier HRS FDA UDI
- Generic Name
- Humeral body prosthesis trial FDA UDI
- Device Name
- Trial Proximal Body 135° FDA UDI
- Model / Reference
- ARS1023304 FDA UDI
- Description
- Trial Proximal Body 135° FDA UDI
Identifiers
- Catalog Number
- ARS1023304 FDA UDI
- Primary DI / UDI-DI
- 00846832094509 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Humeral body prosthesis trial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
Dimensions & Sizes
- Size
- Outer Diameter — 15 Millimeter FDA UDI
Category: Humeral body prosthesis trial
Tornier HRS by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Humeral body prosthesis trial.
- Titan Modular Shoulder System — Smith & Nephew, Inc. · Class I
- Equinoxe — Exactech, Inc. · Class II
- SMR Shoulder — Limacorporate · Class II
- Comprehensive Segmental Revision System (SRS) — Biomet Orthopedics, Inc. · Class II
- Titan™ — Ascension Orthopedics, Inc. · Class I
- Equinoxe — Exactech, Inc. · Class I
- Equinoxe — Exactech, Inc. · Class I
- Arthrex® — Arthrex, Inc. · 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
- Tornier, Inc.
Sources (1)
- FDA UDI 4dc3fdde-cac7-4d3c-945b-f9c10410ce43 36 fields · synced May 30, 2026