AZA005090

GUDID 00841379104643

BONE TAP, 9.0MM

HYHTE HOLDINGS, INC.

Bone tap, reusable
Primary Device ID00841379104643
NIH Device Record Key16ceb019-89c1-433c-ae6c-103620cc626d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAZA005090
Catalog NumberAZA005090
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 Usefalse
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
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
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
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM

Device Dimensions

Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379104643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


[00841379104643]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085244940 - NA2025-01-31 RATCHETING AXIAL HANDLE 2.0 , 1/4 SQ, MIS STYLET ATTACHMENT BACK CAP
00840085244957 - NA2025-01-31 FAVORED ANGLE C/C, EXTENDED TAB (MIS), EXTENDED THREAD, TULIP
00840085244964 - NA2025-01-31 FAVORED ANGLE C/C, EXTENDED TAB (MIS), EXTENDED THREAD, TULIP
00840085272257 - NA2025-01-31 MIS SCREW DRIVER, T27
00840085272493 - NA2025-01-31 TULIP INSERTER, AXIAL, EXT. TAB
00840085274541 - NA2025-01-31 TULIP UNLOCKER, EXT. TAB
00840085274596 - NA2025-01-31 NAVIGATED SCREW DRIVER, MIS T27
00840085274671 - NA2025-01-31 MIS TOWER SCREW DRIVER, T27

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