SDC4K 0240300100

GUDID 07613327562750

Information Management System

STRYKER CORPORATION

Operating room audiovisual data/device management system
Primary Device ID07613327562750
NIH Device Record Key8456ade8-1b8e-4f84-aaea-a7feeccb75a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSDC4K
Version Model Number0240300100
Catalog Number0240300100
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 Batchfalse
Serial Numbertrue
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
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327562750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-12
Device Publish Date2022-04-04

Devices Manufactured by STRYKER CORPORATION

07613327482706 - N/A2025-05-08 System 9 Transfer Shield, Small
07613327163278 - NA2025-04-28
07613327601138 - OptaBlate2025-04-25 Curve 10mm Probe Single Kit
07613327601145 - OptaBlate2025-04-25 Curve 20mm Probe Single Kit
07613327601152 - OptaBlate2025-04-25 Curve 15mm Probe Single Kit
07613327631883 - OptaBlate2025-04-25 Straight 10MM Probe Dual Kit
07613327631890 - OptaBlate2025-04-25 Straight 10MM Probe Single Kit
07613327626391 - ThermaClear2025-04-14

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