EDECGAAZB

GUDID 00841379180708

TORQUE HANDLE

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 ID00841379180708
NIH Device Record Keye756339a-73b8-4f05-a7a9-d22de2e8a6cd
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberEDECGAAZB
Catalog NumberEDECGAAZB
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
GS100841379180708 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379180708]

Moist Heat or Steam Sterilization


[00841379180708]

Moist Heat or Steam Sterilization


[00841379180708]

Moist Heat or Steam Sterilization


[00841379180708]

Moist Heat or Steam Sterilization


[00841379180708]

Moist Heat or Steam Sterilization


[00841379180708]

Moist Heat or Steam Sterilization


[00841379180708]

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

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00840085257513 - NA2024-04-18 DUAL LEAD SCREW
00840085257520 - NA2024-04-18 DUAL LEAD SCREW
00840085257537 - NA2024-04-18 DUAL LEAD SCREW

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