Irrigation Tube Z263001

GUDID 03700512925019

Promepla

Surgical irrigation/aspiration tubing set

• Primary Device ID: 03700512925019
• NIH Device Record Key: 908fddd1-e349-4cb3-b8c1-30cc7c7ea5bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irrigation Tube
• Version Model Number: OSG00499E5ST35
• Catalog Number: Z263001
• Company DUNS: 401020409
• Company Name: Promepla
• 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
GS1	03700512905011 [Primary]
GS1	03700512915010 [Package]; Contains: 03700512905011; Package: Pouch [5 Units]; In Commercial Distribution
GS1	03700512925019 [Package]; Contains: 03700512915010; Package: Box [20 Units]; In Commercial Distribution

FDA Product Code

• GBX: Catheter, Irrigation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-04-06

On-Brand Devices [Irrigation Tube]

• 03700512925040: OSG01199E5ST35
• 03700512925033: OSG01199ST35
• 03700512925026: OSG00499E10ST35
• 03700512925019: OSG00499E5ST35
• 03700512925002: OSG00499ST35
• 03700512915263: ODG05599E5ST35
• 03700512925071: OSG03499ST35
• 03700512925064: OSG03399E5ST35