Tube Sheath

GUDID 04953170044946

MAJ-253 TEFLON SHEATH FOR HX-20U-1 LOOP

OLYMPUS MEDICAL SYSTEMS CORP.

Polypectomy endoscopic ligator, reusable

• Primary Device ID: 04953170044946
• NIH Device Record Key: 94f4a5c8-baca-4be2-b0d4-48b45f119aee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tube Sheath
• Version Model Number: MAJ-253
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170044946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984255

FDA Product Code

• MND: Ligator, esophageal

Sterilization

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

[04953170044946]

Moist Heat or Steam Sterilization

[04953170044946]

Moist Heat or Steam Sterilization

[04953170044946]

Moist Heat or Steam Sterilization

[04953170044946]

Moist Heat or Steam Sterilization

[04953170044946]

Moist Heat or Steam Sterilization

[04953170044946]

Moist Heat or Steam Sterilization

[04953170044946]

Moist Heat or Steam Sterilization

[04953170044946]

Moist Heat or Steam Sterilization

[04953170044946]

Moist Heat or Steam Sterilization

[04953170044946]

Moist Heat or Steam Sterilization

[04953170044946]

Moist Heat or Steam Sterilization

[04953170044946]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [Tube Sheath]

• 04953170044946: MAJ-253 TEFLON SHEATH FOR HX-20U-1 LOOP
• 04953170044885: MAJ-252
• 04953170044823: MAJ-251
• 04953170032967: MAJ-246
• 04953170032851: MAJ-243