1588 AIM 1588010000

GUDID 07613327174328

Camera Control Unit

STRYKER CORPORATION

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 07613327174328
• NIH Device Record Key: 7e30854d-8981-488b-9cc9-66f7d78e86a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1588 AIM
• Version Model Number: 1588010000
• Catalog Number: 1588010000
• 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
• 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	07613327174328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142310

FDA Product Code

• OWN: Confocal optical imaging

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

On-Brand Devices [1588 AIM]

• 07613327174496: Camera Head, C-Mount
• 07613327174427: Inline Camera Head, C-Mount, 10 Ft cable
• 07613327174380: Camera Head with Integrated Coupler
• 07613327174359: Coupler, C-Mount, 18 mm
• 07613327174328: Camera Control Unit