BZ3300000

GUDID 00841379180630

EXPANDABLE TORQUE ADAPTER

HYHTE HOLDINGS, INC.

Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable
Primary Device ID00841379180630
NIH Device Record Keydc14a797-7e95-4228-9973-20bc7be498f6
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBZ3300000
Catalog NumberBZ3300000
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
GS100841379180630 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379180630]

Moist Heat or Steam Sterilization


[00841379180630]

Moist Heat or Steam Sterilization


[00841379180630]

Moist Heat or Steam Sterilization


[00841379180630]

Moist Heat or Steam Sterilization


[00841379180630]

Moist Heat or Steam Sterilization


[00841379180630]

Moist Heat or Steam Sterilization


[00841379180630]

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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00840085265198 - NA2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265204 - NA2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265211 - NA2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265228 - NA2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265235 - NA2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW

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