itool® ApexPulse™ 201-03-00

GUDID 06957277200081

Knee Kit

Apex (Guangzhou) Tools & Orthopedics Co.

Disposable surgical irrigation/aspiration system

• Primary Device ID: 06957277200081
• NIH Device Record Key: 1805c1d2-642e-4053-abc0-3bc78c0a951e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: itool® ApexPulse™
• Version Model Number: 201-03-00
• Catalog Number: 201-03-00
• Company DUNS: 529936792
• Company Name: Apex (Guangzhou) Tools & Orthopedics Co.
• Device Count: 6
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06957277200081 [Primary]
GS1	16957277200088 [Unit of Use]

FDA Product Code

• FQH: Lavage, Jet

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: 2019-02-21
• Device Publish Date: 2016-09-23

On-Brand Devices [itool® ApexPulse™]

• 06957277200173: 6" SPLASH SHIELD
• 06957277200166: FEMORAL BRUSH TIP
• 06957277200159: FAN SPRAY TIP
• 06957277200142: SHOWER SPRAY TIP
• 06957277200135: FEMORAL SPRAY TIP
• 06957277200128: FAN SPRAY TIP WITH SPLASH SHIELD
• 06957277200111: SHOWER SPRAY TIP WITH SPLASH SHIELD
• 06957277200104: Fan Spray Kit
• 06957277200098: Hip Kit
• 06957277200081: Knee Kit
• 06957277200074: Component Kit