NZA033000

GUDID 00840085276521

EGPS, SCREW SHANK DRIVER V2, T27

HYHTE HOLDINGS, INC.

Bone tap, reusable
Primary Device ID00840085276521
NIH Device Record Key1f5b6515-6e6c-4378-8a50-cdcd5e848f1a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNZA033000
Catalog NumberNZA033000
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

Device Dimensions

Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085276521 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

[00840085276521]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-06
Device Publish Date2025-02-26

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085271861 - NA2025-03-06 EGPS, LUMBAR PEDICLE AWL
00840085271878 - NA2025-03-06 EGPS, LUMBAR PEDICLE PROBE, STRAIGHT
00840085271885 - NA2025-03-06 EGPS, LUMBAR PEDICLE PROBE, CURVED
00840085271892 - NA2025-03-06 EGPS, THORACIC PEDICLE PROBE, STRAIGHT
00840085271908 - NA2025-03-06 EGPS, THORACIC PEDICLE PROBE, CURVED
00840085271915 - NA2025-03-06 EGPS, REAMING PILOT DRILL, 3.5MM
00840085271922 - NA2025-03-06 EGPS, CORTICAL, TAP, 3.5MM
00840085271939 - NA2025-03-06 EGPS, CORTICAL, TAP, 4.0MM
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