Device
DYNEX TRIAD dia 2.5mm Trocar LRG
Manufacturer
VILEX LLC
Model: DXT-TTT-17 DI: 00841731152220 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-11 Current Version: 2026-05-19
Description
DYNEX TRIAD dia 2.5mm Trocar LRG
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: a6523dca-e9ef-49d5-9538-b867224c21b9
Distribution Status: In Commercial Distribution
DUNS Number: 117502293
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: 00841731152220
Type: Primary
Issuing Agency: GS1
GMDN
Code: 47457
Name: Orthopaedic trocar blade, reusable
Definition:
A rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.
FDA Product Codes
LXH
Orthopedic manual surgical instrument
Premarket Submissions
Submission Number: K260900
Supplement Number: 000
Device Sizes
Device Size - Size Text: 2.5mm
Device Size - Size Type: Device Size Text, specify
Environmental Conditions
Storage Handling - Storage Handling Type: Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text: N/A