246355S

GUDID H679246355S0

1.5/2.0MM ROTATION CORRECTION PLATE 2H HEAD/5H SHAFT-STERILE

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device IDH679246355S0
NIH Device Record Key057074db-4a53-4851-b806-1c17d8efccd6
Commercial Distribution Discontinuation2019-12-04
Commercial Distribution StatusIn Commercial Distribution
Version Model Number246.355S
Catalog Number246355S
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982170606 [Primary]
HIBCCH679246355S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


[H679246355S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-11
Device Publish Date2015-09-14

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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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