EZ-TRAX™

GUDID 00850006159437

Bracket Silicone (H) 2.4 Standard Round Dia. .375

K1 MEDICAL TECHNOLOGIES, LLC

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device ID00850006159437
NIH Device Record Key8fcdb3ff-6d0b-4f49-88a9-d3c5084059c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZ-TRAX™
Version Model NumberBRACKETASSY-S-2.4-STDRD-0.38
Company DUNS080448429
Company NameK1 MEDICAL TECHNOLOGIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850006159437 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


[00850006159437]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-03
Device Publish Date2020-01-25

On-Brand Devices [EZ-TRAX™]

00850006159581POST
00850006159574THA Broachs
00850006159567THA Broachs
00850006159550TKA Pin Caddy
00850006159543TKA Tibia Trial Insert
00850006159536TKA Trial Base
00850006159369Divider (H) 2.4 x (L) 20
00850006159314Divider (H) 2.4 x (L) 15
00850006159307Divider (H) 2.4 x (L) 14
00850006159284Divider (H) 2.4 x (L) 12
00850006159260Divider (H) 2.4 x (L) 10
00850006159246Divider (H) 2.4 x (L) 08
00850006159222Divider (H) 2.4 x (L) 06
00850006159215Divider (H) 2.4 x (L) 05
00850006159208Divider (H) 2.4 x (L) 04
00850006159192Divider (H) 2.4 x (L) 03
00850006159185Divider (H) 2.4 x (L) 02
00850006159512Bracket Silicone (H) 2.4 Standard Round Dia. 1.00
00850006159505Bracket Silicone (H) 2.4 Standard Round Dia. .875
00850006159499Bracket Silicone (H) 2.4 Standard Round Dia. .750
00850006159475Bracket Silicone (H) 2.4 Standard Round Dia. .500
00850006159451Bracket Silicone (H) 2.4 Standard Round Dia. .4375
00850006159437Bracket Silicone (H) 2.4 Standard Round Dia. .375
00850006159413Bracket Silicone (H) 2.4 Standard Round Dia. .250
00850006159383Bracket Silicone (H) 2.4 Standard Round Dia. 2mm
00850025473026Bracket Assembly Hip Broaches 6 Slots
00850025473002Bracket Assembly Hip Broaches 5 Slots
00850006159819BRACKET (H) 2 x (L) 10 x (P) 002
00850006159802BRACKET (H) 2 x (L) 10 x (P) 001
00850006159796BRACKET (H) 2 x (L) 02 x (P) 002
00850006159789BRACKET (H) 2 x (L) 02 x (P) 001
00850025473125Base Assembly Aluminum (L)25 (W)12 (H)4
00850025473118Base Assembly Aluminum (L)20 (W)11 (H)6
00850025473057Bracket Aluminum (H) 2 x (L) 20 x (P) 116
00850025473040Bracket Aluminum (H) 2 x (L) 20 x (P) 115
00850025473033Bracket Aluminum (H) 2 x (L) 20 x (P) 114
00850025473019Post 1 PC Size .172
00850025473149Lid Assembly Aluminum (L)25 (W)12
00850025473132Lid Assembly Aluminum (L)20 (W)11
00850025473064Insert Aluminum (L)21 (W)12 (H)2
00850025473705Insert Aluminum (L)24 (W)12 (H)2
00850025473460BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .3125
00850025473453BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .250
00850025473439BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .130
00850025473422BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .0625
00850025473187BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .4375
00850025473163BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .375
00850006159352Divider (H) 2.4 x (L) 19
00850006159345Divider (H) 2.4 x (L) 18
00850006159338Divider (H) 2.4 x (L) 17

Trademark Results [EZ-TRAX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EZ-TRAX
EZ-TRAX
88113763 not registered Live/Pending
K1 Medical
2018-09-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.