MICROAIRE® 201-02-00

GUDID 06957277200456

COMPONENT KIT

Apex (Guangzhou) Tools & Orthopedics Co.

Disposable surgical irrigation/aspiration system

• Primary Device ID: 06957277200456
• NIH Device Record Key: ea53c27d-06e9-4c5c-9f44-d6378be48bc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICROAIRE®
• Version Model Number: 201-02-00
• Catalog Number: 201-02-00
• 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: true
• 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	06957277200456 [Primary]
GS1	16957277200453 [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: 2
• Public Version Date: 2020-11-06
• Device Publish Date: 2019-11-26

On-Brand Devices [MICROAIRE®]

• 06957277200555: SPLASH SHIELD, 6 INCH(15.2CM)
• 06957277200548: FEMORAL BRUSH TIP
• 06957277200531: FAN SPRAY TIP
• 06957277200524: SHOWER SPRAY TIP
• 06957277200517: FEMORAL SPRAY TIP
• 06957277200500: FAN SPRAY TIP WITH SPLASH SHIELD
• 06957277200494: SHOWER SPRAY TIP WITH SPLASH SHIELD
• 06957277200487: FAN SPRAY KIT
• 06957277200470: HIP KIT
• 06957277200463: KNEE KIT
• 06957277200456: COMPONENT KIT