KZH010000

GUDID 00840085261480

TABLE FIXATION ARM

HYHTE HOLDINGS, INC.

Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable
Primary Device ID00840085261480
NIH Device Record Key81c29d63-d7f1-4119-992d-d8c018fa4f90
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberKZH010000
Catalog NumberKZH010000
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
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085261480 [Primary]

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


[00840085261480]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-23
Device Publish Date2024-02-15

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085265488 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265495 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265501 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265518 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265525 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265532 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265549 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265556 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW

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