Aqualine SID Suction Irrigation Device

GUDID 10862106000301

CAPSTONE SURGICAL TECHNOLOGIES

Surgical irrigation/aspiration handpiece, single-use

• Primary Device ID: 10862106000301
• NIH Device Record Key: b9048742-3bb1-424e-975c-66abe46a6b88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aqualine SID Suction Irrigation Device
• Version Model Number: S0004
• Company DUNS: 100435824
• Company Name: CAPSTONE SURGICAL TECHNOLOGIES
• 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: 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10862106000301 [Primary]
GS1	20862106000308 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• GCX: Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-01-11