AZE150000

GUDID 00841379165668

MIS TOWER ASSEMBLY TOOL

HYHTE HOLDINGS, INC.

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable
Primary Device ID00841379165668
NIH Device Record Keyf38cf5e4-4fd8-422f-b68b-4f08aac26f9d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAZE150000
Catalog NumberAZE150000
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
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379165668 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


[00841379165668]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-11
Device Publish Date2021-06-03

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085265105 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265112 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265129 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265136 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265143 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265150 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085257469 - NA2024-04-18 DUAL LEAD SCREW
00840085257476 - NA2024-04-18 DUAL LEAD SCREW

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