SmartPulse

GUDID 16972130470446

Apexpulse Knee Kit

Apex (Suzhou) Medical Products Company

Disposable surgical irrigation/aspiration system

• Primary Device ID: 16972130470446
• NIH Device Record Key: ccd8ec10-9839-4904-bcc4-9e5128f26496
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartPulse
• Version Model Number: 201-03-00
• Company DUNS: 554507451
• Company Name: Apex (Suzhou) Medical Products Company
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16972130470446 [Unit of Use]
GS1	26972130470443 [Primary]

FDA Product Code

• FQH: Lavage, Jet

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-04
• Device Publish Date: 2020-10-27

On-Brand Devices [SmartPulse]

• 16972130470453: Apexpulse Hip Kit
• 16972130470446: Apexpulse Knee Kit
• 06972130470456: Apexpulse Hip Kit
• 06972130470449: Apexpulse Knee Kit