414034

GUDID H6794140340

4.5MM TI CORTEX SCREW 34MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw (non-sliding)
Primary Device IDH6794140340
NIH Device Record Keyd9f53180-4244-4cec-92e3-91712ef64caf
Commercial Distribution StatusIn Commercial Distribution
Version Model Number414.034
Catalog Number414034
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
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
GS110886982212443 [Primary]
HIBCCH6794140340 [Secondary]

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


[H6794140340]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-27
Device Publish Date2015-09-14

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

H981PDL432F - NA2026-02-09 INLAY PUSHER-MEDIUM
H981PDL434H - NA2026-02-09 INLAY PUSHER-LARGE
07611819995796 - NA2026-02-09 TAMP
07611819943490 - NA2026-02-09 HEAD IMPACTOR
H679E51157P09 - NA2026-02-09 PLASTIC TIP FOR HEAD IMPACTOR
10886982293060 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 60MM/ XL25
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

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