AJMA95070

GUDID 00841379176572

LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable
Primary Device ID00841379176572
NIH Device Record Key4065dad7-1ff0-4294-9352-d18afc82544a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAJMA95070
Catalog NumberAJMA95070
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

Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter
Length70 Millimeter
Outer Diameter9.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379176572 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

Moist Heat or Steam Sterilization

[00841379176572]

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 - NA2024-10-11LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
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 - NA2024-10-11 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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