ACDA60040

GUDID 00841379178651

6.0 ROD, MIS, STRAIGHT, Ti6Al4VELI

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00841379178651
NIH Device Record Key57e0ea04-42cd-4697-ae25-1d8e69fb9255
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberACDA60040
Catalog NumberACDA60040
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

Device Dimensions

Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379178651 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


[00841379178651]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-18
Device Publish Date2021-06-10

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085261480 - NA2024-02-23 TABLE FIXATION ARM
00840085262708 - NA2024-02-23 SI SCREW DRILL, NAVIGATED, Ø9MM
00840085262715 - NA2024-02-23 SI SCREW DRILL, NAVIGATED, Ø11MM
00840085262722 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø7MM
00840085262739 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø8MM
00840085262746 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø10MM
00840085262753 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø12MM
00840085262760 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø14MM

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