02127138TS

GUDID 10886982306968

3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/38MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID10886982306968
NIH Device Record Key59cd5162-fe42-4dba-9f34-efdcee36ecec
Commercial Distribution StatusIn Commercial Distribution
Version Model Number02.127.138TS
Catalog Number02127138TS
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
GS110886982306968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

Moist Heat or Steam Sterilization


[10886982306968]

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

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

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10886982293244 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25
10886982293251 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 34MM/ XL25
10886982293268 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 36MM/ XL25
10886982293275 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 38MM/ XL25
10886982293282 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 40MM/ XL25
10886982293299 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25

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