1588 1588310130

GUDID 07613327174861

Pendulum Camera Head with Integrated Coupler

STRYKER CORPORATION

Endoscope video camera

• Primary Device ID: 07613327174861
• NIH Device Record Key: 3c29841a-7c44-4565-916f-5f7b282fa634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1588
• Version Model Number: 1588310130
• Catalog Number: 1588310130
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327174861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132785

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[07613327174861]

Liquid Chemical;Ethylene Oxide;Hydrogen Peroxide;Peracetic Acid

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 [1588]

• 07613327363425: Extension Cable for the 1588 AIM Camera System
• 07613327174861: Pendulum Camera Head with Integrated Coupler