350-195-004

GUDID 37613327061643

[Four Spike Irrigator Set, Non-pyrogenic fluid path, Do not use if package is damaged]

STRYKER CORPORATION

Surgical irrigation/aspiration tubing set
Primary Device ID37613327061643
NIH Device Record Key94a8e6c4-6139-42d3-95d9-8dc1c1a5304b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number0350195004
Catalog Number350-195-004
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 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(866)624-4422
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327061642 [Primary]
GS137613327061643 [Package]
Contains: 07613327061642
Package: pack [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2016-09-23

Devices Manufactured by STRYKER CORPORATION

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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
07613327626407 - ThermaClear2025-04-14
07613327626469 - ThermaClear2025-04-14
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