414246

GUDID H6794142460

4.5MM TI SHAFT SCREW 46MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH6794142460
NIH Device Record Key834072c6-6df7-4b0d-ad03-4850445ff78c
Commercial Distribution Discontinuation2020-07-23
Commercial Distribution StatusIn Commercial Distribution
Version Model Number414.246
Catalog Number414246
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982212900 [Primary]
HIBCCH6794142460 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


[H6794142460]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-07
Device Publish Date2015-09-14

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

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10886982293237 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
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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