BH112412A

GUDID 00841379180913

OTLIF SPACER, EXPANDABLE, NON-STERILE

HYHTE HOLDINGS, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID00841379180913
NIH Device Record Keya9d989d0-256e-41b3-926d-cd68c58c500e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBH112412A
Catalog NumberBH112412A
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
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM

Device Dimensions

Width11 Millimeter
Length24 Millimeter
Height17 Millimeter
Angle0 degree
Width11 Millimeter
Length24 Millimeter
Height17 Millimeter
Angle0 degree
Width11 Millimeter
Length24 Millimeter
Height17 Millimeter
Angle0 degree
Width11 Millimeter
Length24 Millimeter
Height17 Millimeter
Angle0 degree
Width11 Millimeter
Length24 Millimeter
Height17 Millimeter
Angle0 degree
Width11 Millimeter
Length24 Millimeter
Height17 Millimeter
Angle0 degree
Width11 Millimeter
Length24 Millimeter
Height17 Millimeter
Angle0 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379180913 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379180913]

Moist Heat or Steam Sterilization


[00841379180913]

Moist Heat or Steam Sterilization


[00841379180913]

Moist Heat or Steam Sterilization


[00841379180913]

Moist Heat or Steam Sterilization


[00841379180913]

Moist Heat or Steam Sterilization


[00841379180913]

Moist Heat or Steam Sterilization


[00841379180913]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-11
Device Publish Date2021-08-03

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