03010437S

GUDID H67903010437S0

12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE

Synthes GmbH

Orthopaedic implantation sleeve, reusable
Primary Device IDH67903010437S0
NIH Device Record Key4281bd9f-813c-4f6d-9530-2446cab9f88d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.010.437S
Catalog Number03010437S
Company DUNS486711679
Company NameSynthes GmbH
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982068781 [Primary]
HIBCCH67903010437S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDSNAIL, FIXATION, BONE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-28
Device Publish Date2015-09-14

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10887587078465 - NA2025-09-19 NONRETAINING SCREWDRIVER BLADE FOR 90DEG SCREWDRIVER
10886982349873 - NA2025-09-01 CANNULATED CIRCULAR REAMER 16MM
10886982349880 - NA2025-09-01 CANNULATED CIRCULAR REAMER 18MM
10886982349897 - NA2025-09-01 CANNULATED CIRCULAR REAMER 20MM
10886982349903 - NA2025-09-01 CANNULATED CIRCULAR REAMER 22MM

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