497242

GUDID H9814972420

TI INFERIOR CRADLE-SIZE 10 70MM RADIUS

Synthes GmbH

Vertical expandable prosthetic rib system
Primary Device IDH9814972420
NIH Device Record Key317283d1-ab83-40f4-80eb-90c971fee419
Commercial Distribution StatusIn Commercial Distribution
Version Model Number497.242
Catalog Number497242
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034788159 [Primary]
HIBCCH9814972420 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDIProsthesis, rib replacement

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


[H9814972420]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-27
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

10886982350435 - NA2026-02-19 HALF BENNETT SMALL/LEFT
10886982350442 - NA2026-02-19 HALF BENNETT SMALL/RIGHT
10886982350459 - NA2026-02-19 HALF BENNETT LARGE/LEFT
10886982350466 - NA2026-02-19 HALF BENNETT LARGE/RIGHT
10886982351579 - NA2026-02-19 SHOULDER HOOK 2.2 MM TIP / 235 MM LENGTH
10886982351661 - NA2026-02-19 T-HANDLE AO CONNECTOR
10886982351678 - NA2026-02-19 T-HANDLE LARGE AO CONNECTOR
10886982361288 - NA2026-02-19 5MM AWL, QC

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