AZE060480

GUDID 00841379166146

GUIDE WIRE, THREADED TIP, 1.4MM X XXXMM, NITINOL,

HYHTE HOLDINGS, INC.

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual
Primary Device ID00841379166146
NIH Device Record Key1aedd85a-0e45-46aa-8c09-53ed11f56c2e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAZE060480
Catalog NumberAZE060480
Company DUNS073029645
Company NameHYHTE HOLDINGS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM

Device Dimensions

Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter
Guidewire Diameter1.4 Millimeter
Guidewire Length480 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379166146 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


[00841379166146]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085201431 - NA2021-06-11 MIS MODULAR REDUCER DRIVER
00841379139942 - NA2021-06-11 ROD BENDER
00841379139973 - NA2021-06-11 PARALLEL COMPRESSOR
00841379160571 - NA2021-06-11 RATCHETING EGG HANDLE, 1/4 SQ.
00841379160588 - NA2021-06-11 RATCHETING T HANDLE, 1/4 SQ
00841379165262 - NA2021-06-11 MIS TARGETING NEEDLE HOLDER
00841379165477 - NA2021-06-11 MIS GUIDE WIRE GRIPPER
00841379165491 - NA2021-06-11 MIS SCREW DRIVER STYLET, NITINOL

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