02152455S

GUDID 10886982307781

4.0MM BLUNTED POINT SCHANZ SCREW 55MM THRD/150MM/STERILE

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID10886982307781
NIH Device Record Key2eb33c66-a23d-4959-afa1-bcec0dca1c90
Commercial Distribution StatusIn Commercial Distribution
Version Model Number02.152.455S
Catalog Number02152455S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
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Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982307781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSNSoftware for diagnosis/treatment

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


[10886982307781]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-21
Device Publish Date2021-10-13

Devices Manufactured by SYNTHES (U.S.A.) LP

10886982297280 - NA2024-09-11 SCHANZ PIN REMOVAL TOOL
H9814871830 - Click'X2024-09-11 7.0MM TI CLICK'X® MONOAXIAL PEDICLE SCREW 90MM THRD LENGTH
H9812982060 - NA2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
H6792042280 - NA2024-07-24 3.5MM SHAFT SCREW 28MM
H6792042320 - NA2024-07-24 3.5MM SHAFT SCREW 32MM
H6792042340 - NA2024-07-24 3.5MM SHAFT SCREW 34MM
H6792042360 - NA2024-07-24 3.5MM SHAFT SCREW 36MM
H6792042380 - NA2024-07-24 3.5MM SHAFT SCREW 38MM

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