StrykeFlow 250-070-520

GUDID 37613327061360

2, Disposable Suction/Irrigator with Disposable Tip

STRYKER CORPORATION

Endoscopic irrigation/aspiration pump

• Primary Device ID: 37613327061360
• NIH Device Record Key: ffb0ef08-b6af-4187-bcae-69d8c711a571
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StrykeFlow
• Version Model Number: 0250070520
• Catalog Number: 250-070-520
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327061369 [Primary]
GS1	37613327061360 [Package]; Contains: 07613327061369; Package: pack [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954726

FDA Product Code

• GCX: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [StrykeFlow]

• 37613327061469: Pressure System Disposable Suction/Irrigator, Dual Spike Tubing
• 37613327061407: Disposable Suction / Irrigation Tip, Standard, Vented, Metal Finish
• 37613327061391: 2, Disposable Suction/Irrigator without Disposable Tip
• 37613327061360: 2, Disposable Suction/Irrigator with Disposable Tip
• 37613327061353: Pressure System Disposable Suction/Irrigator, Single Spike Tubing
• 37613327061322: Dual Irrigation Adapter, Disposable
• 07613327052114: Reusable Suction Irrigation Tip, Stone Scooper, Metal Finish
• 07613327052107: Reusable Suction Irrigation Tip, Standard, Non-Vented, Metal Finish
• 07613327052091: Reusable Suction Irrigation Tip, Standard, Vented, Metal Finish
• 07613327052084: Reusable Suction Irrigation Tip, Standard, Vented, Non-Reflective Finish
• 07613327052077: Reusable Suction Irrigation Tip, Standard, Non-Vented, Non-Reflective Finish
• 07613327052060: Reusable Suction Irrigation Tip, Hydrodissection, Non-Reflective Finish
• 07613327052053: Reusable Suction Irrigation Tip, Pool Suction, Non-Reflective Finish
• 07613327052046: Reusable Suction Irrigation Tip, Pool Suction, Non-Reflective Finish
• 07613327052039: Reusable Suction Irrigation Tip, Standard, Vented, Non-Reflective Finish
• 07613327052022: Reusable Suction Irrigation Tip, Standard, Vented, Non-Reflective Finish
• 07613327052015: Reusable Suction Irrigation Tip, Standard, Vented, Non-Reflective Finish
• 07613327052008: Reusable Suction Irrigation Tip, Standard, Non-Vented, Metal Finish
• 07613327051995: Reusable Suction Irrigation Tip, Standard, 2-Hole, Metal Finish
• 07613327051988: Reusable Suction Irrigation Tip, Standard, 1-Hole, Metal Finish
• 07613327051858: Reusable Suction Irrigation Tip, Aspiration Needle, Metal Finish
• 07613327051841: Adapter for Davol Nezhat/Dorsey Suction/Irrigation Probes with Three O-Rings
• 07613327051827: Laser Fiber Guide, Flexible
• 07613327051810: Laser Fiber Guide
• 07613327051803: Laser Fiber Guide, Flexible
• 07613327051797: Reusable Suction Irrigation Tip, Standard, Vented, Metal Finish
• 07613327051780: Reusable Suction Irrigation Tip, Standard, Non-Vented, Metal Finish
• 07613327051773: Reusable Suction Irrigation Tip, Standard, Vented, Metal Finish
• 07613327051766: Reusable Suction Irrigation Tip, Hydrodissection, Metal Finish
• 07613327051759: Reusable Suction Irrigation Tip, Pool Suction, Metal Finish
• 07613327051742: Reusable Suction Irrigation Tip, Standard, Vented, Metal Finish
• 07613327051735: Reusable Suction Irrigation Tip, Standard, Vented, Metal Finish
• 07613327051728: Reusable Suction Irrigation Tip, Pool Suction, Metal Finish
• 07613327051711: Reusable Suction Irrigation Tip, Standard, Vented, Metal Finish