X8000 0220200000

GUDID 07613327051360

Xenon Light Source

STRYKER CORPORATION

Endoscopic light source, line-powered

• Primary Device ID: 07613327051360
• NIH Device Record Key: 0e20ce31-c29c-40b1-a3ae-2ab4d85921c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X8000
• Version Model Number: 0220200000
• Catalog Number: 0220200000
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
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• 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
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• 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	07613327051360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961971

FDA Product Code

• FCW: Light source, fiberoptic, routine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-23

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• 07613327262889 - XIA II: 2025-03-10 ROD ROTATION FORCEPS
• 07613327263169 - XIA II: 2025-03-10 POLYAXIAL SCREWDRIVER, XIA 3 STYLE
• 07613327263237 - XIA II: 2025-03-10 SHAFT FOR POLYAXIAL SCREWDRIVER XIA 3 STYLE
• 07613327266887 - MANTIS: 2025-03-10 TORQUE WRENCH
• 07613327267044 - MANTIS Redux: 2025-03-10 SHAFT FOR POLYAXIAL SCREWDRIVER
• 07613327267785 - AVS: 2025-03-10 AL SPACER IMPACTOR STRAIGHT