AZA026480

GUDID 00841379166115

GUIDE WIRE, SHARP 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 ID00841379166115
NIH Device Record Keyb200ee5d-7bcc-4022-950a-990509742ba8
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAZA026480
Catalog NumberAZA026480
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
GS100841379166115 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

Moist Heat or Steam Sterilization


[00841379166115]

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.

00840085201424 - NA2021-06-11 MIS TAB BREAKER COUNTER TORQUE
00841379161820 - NA2021-06-11 EXTERNAL 1/4SQ W/ TRINKLE
00841379165248 - NA2021-06-11 11Ga. X 150MM TARGETING NEEDLE
00841379165255 - NA2021-06-11 8Ga. X 150MM TARGETING NEEDLE
00841379165484 - NA2021-06-11 MIS SCREW DRIVER STYLET SHUTTLE
00841379165651 - NA2021-06-11 MIS SCREW TOWER
00841379165668 - NA2021-06-11 MIS TOWER ASSEMBLY TOOL
00841379165729 - NA2021-06-11 MIS EXTENDED TAB DIVIDER

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.