Device
RI UNIVERSAL TRACKING INSERT F
Manufacturer
Smith & Nephew, Inc.
Model: ROB30025 Catalog: ROB30025 DI: 00885556924174 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-11 Current Version: 2026-05-19
Description
RI UNIVERSAL TRACKING INSERT F
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 33ea5710-28d3-4081-81e8-c226f165ebc8
Distribution Status: In Commercial Distribution
DUNS Number: 045483575
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00885556924174
Type: Primary
Issuing Agency: GS1
GMDN
Code: 12143
Name: Instrument tray, reusable
Definition:
A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
FDA Product Codes
OLO
Orthopedic stereotaxic instrument
Premarket Submissions
Submission Number: K252841
Supplement Number: 000