AZA060085

GUDID 00841379140535

NAVIGATED, CANNULATED, CORTICAL, BONE TAP,

HYHTE HOLDINGS, INC.

Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable
Primary Device ID00841379140535
NIH Device Record Key3fc23ef0-d8e5-49c5-bca9-edbef8a68186
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAZA060085
Catalog NumberAZA060085
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
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

Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter
Outer Diameter8.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379140535 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


[00841379140535]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

Devices Manufactured by HYHTE HOLDINGS, INC.

00841379178637 - NA2021-06-18 6.0 ROD, MIS, STRAIGHT, Ti6Al4VELI
00841379178644 - NA2021-06-18 6.0 ROD, MIS, STRAIGHT, Ti6Al4VELI
00841379178651 - NA2021-06-18 6.0 ROD, MIS, STRAIGHT, Ti6Al4VELI
00841379178668 - NA2021-06-18 6.0 ROD, MIS, STRAIGHT, Ti6Al4VELI
00841379178675 - NA2021-06-18 6.0 ROD, MIS, STRAIGHT, Ti6Al4VELI
00841379178682 - NA2021-06-18 6.0 ROD, MIS, STRAIGHT, Ti6Al4VELI
00841379178699 - NA2021-06-18 6.0 ROD, MIS, STRAIGHT, Ti6Al4VELI
00841379178705 - NA2021-06-18 6.0 ROD, MIS, STRAIGHT, Ti6Al4VELI

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