ECECGAAZE

GUDID 00841379163251

OFFSET-T, L, 1/4 SQ, TORQUE, ALUMINUM CORE, INTERNAL, NON-CANNULATED, 80 IN-LBS

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 ID00841379163251
NIH Device Record Key306dab51-1497-40dd-aec0-7107e1938426
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberECECGAAZE
Catalog NumberECECGAAZE
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
GS100841379163251 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379163251]

Moist Heat or Steam Sterilization


[00841379163251]

Moist Heat or Steam Sterilization


[00841379163251]

Moist Heat or Steam Sterilization


[00841379163251]

Moist Heat or Steam Sterilization


[00841379163251]

Moist Heat or Steam Sterilization


[00841379163251]

Moist Heat or Steam Sterilization


[00841379163251]

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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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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