AWI

GUDID 06957277200326

PULSE IRRIGATOR

Apex (Guangzhou) Tools & Orthopedics Co.

Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system

• Primary Device ID: 06957277200326
• NIH Device Record Key: ff60a464-a068-43e4-b628-1310e73f6c21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AWI
• Version Model Number: 209-00
• Company DUNS: 529936792
• Company Name: Apex (Guangzhou) Tools & Orthopedics Co.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06957277200326 [Primary]

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: 2019-07-22

On-Brand Devices [AWI]

• 06957277200692: PULSE IRRIGATOR
• 06957277200449: HYDRA ADAPTOR
• 06957277200371: STANDARD TIP
• 06957277200364: STANDARD TIP
• 06957277200357: STANDARD TIP
• 06957277200340: TUNNEL TIP
• 06957277200333: PULSE IRRIGATOR
• 06957277200326: PULSE IRRIGATOR
• 16957277200804: TRUNK-S IRRIGATION BAG
• 06957277200814: TRUNK-S IRRIGATION BAG
• 16957277200774: TRUNK-L IRRIGATION KIT
• 06957277200784: TRUNK-L IRRIGATION KIT
• 16957277200743: TRUNK-S IRRIGATION KIT
• 06957277200753: TRUNK-S IRRIGATION KIT
• 16957277200712: EXTREMITY IRRIGATION KIT
• 06957277200722: EXTREMITY IRRIGATION KIT
• 16957277200682: PULSE IRRIGATOR WITH HYDRA ADAPTOR
• 16957277201597: TRUNK IRRIGATION BAG
• 16957277201580: EXTREMITY IRRIGATION BAG
• 16957277200354: STANDARD TIP
• 06957277202610: SACRAL/TRUNK/BODY KIT
• 06957277202603: EXTREMITY/ARMS/LEGS KIT