RC1001235

GUDID 00840085269097

SI SCREW, FIXED, COMPRESSION THREAD, ASTURACOAT FINISH

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable
Primary Device ID00840085269097
NIH Device Record Keya4b67633-335e-4634-9f1f-e802f1d519c0
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberRC1001235
Catalog NumberRC1001235
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

Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter
Length35 Millimeter
Outer Diameter12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085269097 [Primary]

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

Moist Heat or Steam Sterilization

[00840085269097]

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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