497257

GUDID H9814972570

TI S-HOOK-LEFT

Synthes GmbH

Vertical expandable prosthetic rib system
Primary Device IDH9814972570
NIH Device Record Key7776f046-11c3-4d59-b8e8-a7482737c9f0
Commercial Distribution StatusIn Commercial Distribution
Version Model Number497.257
Catalog Number497257
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
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
GS110705034788289 [Primary]
HIBCCH9814972570 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDIProsthesis, rib replacement

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

Moist Heat or Steam Sterilization


[H9814972570]

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

H6792050550 - NA2025-02-20 3.5MM CANNULATED SCREW PARTIALLY THREADED/55MM
H6794089050 - NA2025-02-20 7.3MM TI CANNULATED SCREW 16MM THREAD/105MM
07612334285515 - VOLT2024-12-19 VOLT(TM) PROX HUM IMP & INSTR 1 HIGH 3/3 WIDTH ALUM TRAY
10886982346896 - MAXFRAME2024-12-17 MAXFRAME AUTOSTRUT (TM) SOFTWARE
10886982347572 - NA2024-12-11 RFN-ADVANCED POLYMER INLAY STERILE
10886982330994 - VOLT2024-11-22 2.0MM VOLT(TM) ADAPTION PLATE 12H/65MM
07612334260079 - KINCISE2024-11-08 KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE
07612334268587 - KINCISE2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID

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