Protech XL

GUDID 05060602250543

ENDOSCOPIC STORAGE COVER

MEDITECH ENDOSCOPY LTD

Endoscope sheath, single-use

• Primary Device ID: 05060602250543
• NIH Device Record Key: 6c9971f9-b369-4856-9c45-7bf477a1bebc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protech XL
• Version Model Number: INOV8-044
• Company DUNS: 219397009
• Company Name: MEDITECH ENDOSCOPY LTD
• Device Count: 50
• 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: 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	05060602250543 [Unit of Use]
GS1	05060602250567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191011

FDA Product Code

• OCU: Endoscopic Storage Cover

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-09
• Device Publish Date: 2026-01-30

Devices Manufactured by MEDITECH ENDOSCOPY LTD

• 05060602250307 - Protech S: 2026-02-09 ENDOSCOPIC STORAGE COVER
• 05060602250543 - Protech XL: 2026-02-09 ENDOSCOPIC STORAGE COVER
• 05060602250543 - Protech XL: 2026-02-09 ENDOSCOPIC STORAGE COVER
• 05060602250291 - Protech L: 2026-02-05 ENDOSCOPIC STORAGE COVER
• 05060602250024 - ECO EZ CLEANSE: 2023-09-04 ECO EZ CLEANSE
• 05060602250017 - VALVESAFE: 2023-09-01 VALVESAFE