GUDID 00840682114462

PARALLEL DESIGN

Rectal ultrasound imaging system transducer

• Primary Device ID: 00840682114462
• NIH Device Record Key: ad930cab-9a16-4357-a5ff-bd273a824596
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: IC5-9W-RS
• Company DUNS: 391532137
• Company Name: PARALLEL DESIGN
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682114462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131937

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

Devices Manufactured by PARALLEL DESIGN

• 00840682110976 - NA: 2019-01-18
• 00840682111157 - NA: 2019-01-18
• 00840682111263 - NA: 2019-01-18
• 00840682111416 - NA: 2019-01-18
• 00840682115346 - NA: 2019-01-18
• 00840682124355 - NA: 2019-01-18
• 00840682124768 - NA: 2019-01-18
• 00840682136075 - NA: 2018-11-02