GZC10D18D

GUDID 00840085211072

LLIF IMPLANT TRIAL, MODULAR, ANGLED LEFT

HYHTE HOLDINGS, INC.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial
Primary Device ID00840085211072
NIH Device Record Keyedb283d8-1b45-41d4-ade0-2fced39cb782
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberGZC10D18D
Catalog NumberGZC10D18D
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

Device Dimensions

Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree
Width24 Millimeter
Height18 Millimeter
Angle15 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085211072 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


[00840085211072]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

Devices Manufactured by HYHTE HOLDINGS, INC.

00841379140566 - N/A2021-07-30 SCREWDRIVER
00841379153078 - N/A2021-07-30 STRAIGHT ROD
00841379153085 - N/A2021-07-30 STRAIGHT ROD
00841379153092 - N/A2021-07-30 STRAIGHT ROD
00841379153108 - N/A2021-07-30 STRAIGHT ROD
00841379153115 - N/A2021-07-30 STRAIGHT ROD
00841379153122 - N/A2021-07-30 STRAIGHT ROD
00841379153139 - N/A2021-07-30 STRAIGHT ROD

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