itool® ApexPulse™ 201-00-50

GUDID 06957277200142

SHOWER SPRAY TIP

Apex (Guangzhou) Tools & Orthopedics Co.

Surgical irrigation handpiece nozzle Surgical irrigation system nozzle Surgical irrigation system nozzle Surgical irrigation system nozzle Surgical irrigation system nozzle Surgical irrigation system nozzle Surgical irrigation system nozzle Surgical irrigation system nozzle Surgical irrigation system nozzle Surgical irrigation system nozzle

• Primary Device ID: 06957277200142
• NIH Device Record Key: f4f2a70a-b421-467c-a553-e7765e58bbd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: itool® ApexPulse™
• Version Model Number: 201-00-50
• Catalog Number: 201-00-50
• 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	06957277200142 [Primary]
GS1	16957277200149 [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