432067

GUDID H6794320670

3.5MM 90 DEG TI CANN LC-ANGLED BLADE PLATE 6 HOLES/35MM

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device IDH6794320670
NIH Device Record Keya02462f9-0c1a-4a79-a042-e09683218aa5
Commercial Distribution Discontinuation2019-06-15
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number432.067
Catalog Number432067
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
GS110886982217820 [Primary]
HIBCCH6794320670 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTWAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


[H6794320670]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-17
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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