SPINAL HOOK SYSTEM™

GUDID 08800015941433

U&I CORPORATION

Spinal implant trial
Primary Device ID08800015941433
NIH Device Record Key581c2b2e-91ec-4626-9e9c-b7ab12b35e29
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPINAL HOOK SYSTEM™
Version Model NumberSH0709-A8
Company DUNS688811082
Company NameU&I CORPORATION
Device Count1
DM Exempttrue
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS108800015941433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


[08800015941433]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-17
Device Publish Date2016-10-19

On-Brand Devices [SPINAL HOOK SYSTEM™]

08800015941464SH1960
08800015941457SH0711-A6
08800015941440SH0711-A5
08800015941433SH0709-A8
08800015941426SH0709-A7
08800015941419SH0709-A2
08800015941402SH0707-A7
08800015941396SH0509-A2
08800015941372SH0507-A3
08800015941365SH0507-A2
08800015941358SH0505-A2
08800015941341SH0504-A2
08800015938334SH0060
08800015938327SH0050
08800015938310SH0040
08800015938303SH0032
08800015938297SH0031
08800015938280SH0030
08800015933070SH1948
08800015933063SH1940
08800015933056SH1930
08800015933049SH1920
08800015933032SH0809-A1
08800015933025SH0807-A1
08800015933018SH0805-A1
08800015933001SH0804-A1
08800015932998SH0711-A2
08800015932981SH0709-A6
08800015932974SH0709-A5
08800015932967SH0707-A2
08800015932950SH0706-A2
08800015932943SH0509-A4
08800015932936SH0507-A4
08800015932929SH0025
08800015932912SH0024
08800037523150SH0507-A7
08800037523143SH0023
08800037523136SH0022
08800037521200SHS1051
08800037521194SHS1050
08800037556929SH0809-A1
08800037556912SH0807-A1
08800037556905SH0805-A1
08800037556899SH0804-A1
08800037556400SH0711-A2
08800037556394SH0709-A8
08800037556387SH0709-A7
08800037556370SH0709-A2
08800037556363SH0707-A7
08800037556356SH0707-A2

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