STERISPINE PS

GUDID 03760219916666

SAFE ORTHOPAEDICS

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Primary Device ID03760219916666
NIH Device Record Key6d5f60d6-2eb1-41cd-974f-2f74c692cfff
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERISPINE PS
Version Model NumberKITMC435
Company DUNS261875917
Company NameSAFE ORTHOPAEDICS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760219916666 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-09
Device Publish Date2020-10-01

On-Brand Devices [STERISPINE PS]

03760219910022KITANCMIS
03760219912699KITRMI1380S
03760219912675KITRMI100
03760219912651KITRMI545
03760219912286KITMCL755
03760219912262KITMCL750
03760219912248KITMCL745
03760219912224KITMCL740
03760219912200KITMCL735
03760219912187KITMCL655
03760219912163KITMCL650
03760219912149KITMCL645
03760219912125KITMCL640
03760219912101KITMCL635
03760219912088KITMCL550
03760219912064KITMCL545
03760219912040KITMCL540
03760219912026KITMCL535
03760219912002KITMCL530
03760219911791KITMC755
03760219911777KITMC750
03760219911753KITM755
03760219911739KITM750
03760219911579KITM655
03760219911555KITM530
03760219911531KITM550
03760219911517KITM545
03760219911494KITMC655
03760219911470KITMC550
03760219911456KITMC545
03760219911432KITMC530
03760219911197KITRMI180S
03760219911135KITRMI120S
03760219911111KITRMI580
03760219911098KITRMI570
03760219911074KITRMI560
03760219911050KITRMI550
03760219911036KITRMI540
03760219911012KITRMI535
03760219910992KITRMI530
03760219910961KITMC635
03760219910497KITM635
03760219910183KITMC745
03760219910176KITMC740
03760219910169KITMC735
03760219910152KITMC650
03760219910145KITMC645
03760219910138KITMC640
03760219910121KITMC540
03760219910114KITMC535

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