AJMA95080

GUDID 00841379176596

LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable
Primary Device ID00841379176596
NIH Device Record Key9ff82458-37b0-46f7-9255-93063e12b02a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAJMA95080
Catalog NumberAJMA95080
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

Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter
Length80 Millimeter
Outer Diameter9.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379176596 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


[00841379176596]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-10-11
Device Publish Date2021-05-28

Devices Manufactured by HYHTE HOLDINGS, INC.

00841379176572 - NA2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
00841379176589 - NA2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
00841379176596 - NA2024-10-11LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
00841379176596 - NA2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
00841379176602 - NA2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
00841379176619 - NA2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
00841379176626 - NA2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
00841379176633 - NA2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
00841379176657 - NA2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING

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