SDC3 0240060102

GUDID 07613327056174

Device Control Package

STRYKER CORPORATION

Endoscopic device remote control
Primary Device ID07613327056174
NIH Device Record Key89b5b4d9-be20-4062-a89e-9683f01f8280
Commercial Distribution StatusIn Commercial Distribution
Brand NameSDC3
Version Model Number0240060102
Catalog Number0240060102
Company DUNS187502109
Company NameSTRYKER CORPORATION
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 Usefalse
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(866)624-4422
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327056174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [SDC3]

07613327056174Device Control Package
07613327056167Voice Control Package
07613327056150HD Information Management System

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