RC0001065

GUDID 00840085268656

SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable
Primary Device ID00840085268656
NIH Device Record Keyfd3b473f-35ec-48e5-8892-def7e7746820
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberRC0001065
Catalog NumberRC0001065
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
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 Dimensions

Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter
Length65 Millimeter
Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085268656 [Primary]

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

[00840085268656]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-08-21
Device Publish Date2024-02-13

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085233319 - NA2024-09-11 TRIAL INSERTER
00840085233326 - NA2024-09-11 IMPLANT INSERTER
00840085233531 - NA2024-09-11 SPACER INSERTER, FORCEPS
00840085242458 - NA2024-09-11 FULL PLATE INSERTER
00840085242472 - NA2024-09-11 NAIL INSERTION TOOL
00840085268496 - NA2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH
00840085268502 - NA2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH
00840085268519 - NA2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH
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