02127180TS

GUDID 10886982307262

3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/80MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID10886982307262
NIH Device Record Key36668262-de80-4fe9-b24b-f9f32f57438f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number02.127.180TS
Catalog Number02127180TS
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
GS110886982307262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

Moist Heat or Steam Sterilization


[10886982307262]

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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H6792042360 - NA2024-07-24 3.5MM SHAFT SCREW 36MM
H6792042380 - NA2024-07-24 3.5MM SHAFT SCREW 38MM

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