ACDA60030

GUDID 00841379178637

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 ID00841379178637
NIH Device Record Keyb3fc73aa-4800-40cd-a10f-7dabd190ed7c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberACDA60030
Catalog NumberACDA60030
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
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter
Outer Diameter6 Millimeter
Length30 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379178637 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

Moist Heat or Steam Sterilization


[00841379178637]

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.

00840085233623 - NA2021-08-04 ZERO PLATE TRIAL
00840085233630 - NA2021-08-04 ZERO PLATE TRIAL
00840085233647 - NA2021-08-04 ZERO PLATE TRIAL
00840085233654 - NA2021-08-04 ZERO PLATE TRIAL
00840085233661 - NA2021-08-04 ZERO PLATE TRIAL
00840085233678 - NA2021-08-04 ZERO PLATE TRIAL
00840085233685 - NA2021-08-04 ZERO PLATE TRIAL
00840085233692 - NA2021-08-04 ZERO PLATE TRIAL

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