EACEASADZ

GUDID 00841379159834

AXIAL HANDLE, S, AO, FIXED, ALUMINUM CORE, INTERNAL, NON-CANNULATED, SPIN TOP

HYHTE HOLDINGS, INC.

Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal
Primary Device ID00841379159834
NIH Device Record Key226a5fdf-6db7-49d4-a3a4-da0856dfbed3
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberEACEASADZ
Catalog NumberEACEASADZ
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
GS100841379159834 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379159834]

Moist Heat or Steam Sterilization


[00841379159834]

Moist Heat or Steam Sterilization


[00841379159834]

Moist Heat or Steam Sterilization


[00841379159834]

Moist Heat or Steam Sterilization


[00841379159834]

Moist Heat or Steam Sterilization


[00841379159834]

Moist Heat or Steam Sterilization


[00841379159834]

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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