SondeAR - Air Charged Catheter

GUDID 10627825008225

Laborie Medical Technologies Canada ULC

Urodynamic manometric catheter, non-electronic

• Primary Device ID: 10627825008225
• NIH Device Record Key: 114224b5-af71-481e-a1bc-1523b4028f84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SondeAR - Air Charged Catheter
• Version Model Number: SAR-AC
• Company DUNS: 203383526
• Company Name: Laborie Medical Technologies Canada ULC
• 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627825008228 [Primary]
GS1	10627825008225 [Package]; Contains: 00627825008228; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• FEN: DEVICE, CYSTOMETRIC, HYDRAULIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

On-Brand Devices [SondeAR - Air Charged Catheter]

• 10627825008249: SAR-PC
• 10627825008232: SAR-AL
• 10627825008225: SAR-AC