BZ4100000

GUDID 00840085242250

EXPANDABLE INSERTER, SIMPLIFIED, TORQUE ADAPTER

HYHTE HOLDINGS, INC.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device ID00840085242250
NIH Device Record Key5b75599a-ef18-411f-a653-7eec5acc546e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBZ4100000
Catalog NumberBZ4100000
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085242250 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085242250]

Moist Heat or Steam Sterilization


[00840085242250]

Moist Heat or Steam Sterilization


[00840085242250]

Moist Heat or Steam Sterilization


[00840085242250]

Moist Heat or Steam Sterilization


[00840085242250]

Moist Heat or Steam Sterilization


[00840085242250]

Moist Heat or Steam Sterilization


[00840085242250]

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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