02127144TS

GUDID 10886982307149

3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/44MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID10886982307149
NIH Device Record Key80306ec2-79fd-4a46-af47-943bdee26db7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number02.127.144TS
Catalog Number02127144TS
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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 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
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
GS110886982307149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


[10886982307149]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-09
Device Publish Date2021-04-01

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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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