KZA040000

GUDID 00840085214424

BALL TIP PROBE, 90°

HYHTE HOLDINGS, INC.

Bone nail guidewire, reusable Bone nail guidewire, reusable Bone nail guidewire, reusable Bone nail guidewire, reusable Bone nail guidewire, reusable Bone nail guidewire, reusable Bone nail guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable
Primary Device ID00840085214424
NIH Device Record Key706449a4-948e-47ac-beac-cd55b4b7ffca
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberKZA040000
Catalog NumberKZA040000
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 Usetrue
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
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM

Device Dimensions

Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085214424 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


[00840085214424]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-11
Device Publish Date2021-08-03

Devices Manufactured by HYHTE HOLDINGS, INC.

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00840085262715 - NA2024-02-23 SI SCREW DRILL, NAVIGATED, Ø11MM
00840085262722 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø7MM
00840085262739 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø8MM
00840085262746 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø10MM
00840085262753 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø12MM
00840085262760 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø14MM

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