ClearTract

GUDID 00850041415154

2-Way 100% Silicone, 16Fr X 10ml, ClearTract SPT Catheter

PATHWAY, LLC

Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial

• Primary Device ID: 00850041415154
• NIH Device Record Key: aa189afe-fdf6-405e-a034-a256f1009fa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearTract
• Version Model Number: 211610SPT
• Company DUNS: 080312381
• Company Name: PATHWAY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850041415154 [Primary]

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-29
• Device Publish Date: 2024-05-21

On-Brand Devices [ClearTract]

• 00850041415161: 2-Way 100% Silicone, 18Fr X 10ml, ClearTract SPT Catheter
• 00850041415154: 2-Way 100% Silicone, 16Fr X 10ml, ClearTract SPT Catheter
• 00850041415147: 2-Way 100% Silicone, 16Fr X 5ml, ClearTract SPT Catheter
• 00850041415130: 2-Way 100% Silicone, 14Fr X 10ml, ClearTract SPT Catheter