R3 (UDI 71369764)
Manufactured by Smith & Nephew, Inc.
Device Regulatory Overview
The R3 (Model/Catalog Number: 71369764) is a medical device manufactured by Smith & Nephew, Inc.. This product is indexed under FDA Product Code / Category Classification MRA within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816...
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener....
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690...
Technical Specifications
- Model Number
- 71369764
- Product Code / EMDN
- MRA
- Device Name
- R3 36MM INNER DIAMETER CERAMIC ACETABULAR TRIAL LINER 64MM OUTER DIAMETER
- Database Sync Date
- 2026-08-09 09:23:31
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of R3?
The registered manufacturer of record for R3 is Smith & Nephew, Inc..
What is the Primary UDI-DI identifier for R3?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 71369764.
What classification code is assigned to this device?
This device is registered under product classification code MRA.
Similar Classification Devices (MRA)
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint