DBK9

GUDID 07613327169331

STRYKER CORPORATION

External cuff/pad connection tubing
Primary Device ID07613327169331
NIH Device Record Keye0e62f82-f6fe-41b4-8127-5133db9024f7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDBK9
Catalog NumberDBK9
Company DUNS078470558
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327169331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWJSystem, thermal regulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2016-09-24

Devices Manufactured by STRYKER CORPORATION

07613327625134 - Steri-Shield2025-03-06 8 SURGICAL HELMET
07613327625202 - Steri-Shield2025-03-06 8 BATTERY
07613327627039 - STERI-SHIELD2025-03-06 8 SURGICAL HELMET WITH LIGHT
07613327652154 - ProCuity2025-03-04 ProCuity L + IsoFlex
07613327652161 - ProCuity2025-03-04 ProCuity LE + IsoFlex
07613327652178 - ProCuity2025-03-04 ProCuity LE + ComfortGel
07613327652192 - ProCuity2025-03-04 ProCuity LEX + ComfortGel
07613327652215 - ProCuity2025-03-04 ProCuity LEX + IsoFlex

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