Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing

GUDID B3901912000T1

SURETEK MEDICAL

Paranasal sinus irrigation catheter

• Primary Device ID: B3901912000T1
• NIH Device Record Key: fd6484ec-801f-4fb7-b2cc-13225508fcec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing
• Version Model Number: 19-12000T
• Company DUNS: 785616934
• Company Name: SURETEK MEDICAL
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3901912000T1 [Primary]

FDA Product Code

• KAM: Cannula, Sinus

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: 2021-06-23
• Device Publish Date: 2021-06-15

On-Brand Devices [Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing]

• B390191200T1: 191200T
• B3901912000T1: 19-12000T
• B3901912050T1: 19-12050T