Loop

GUDID 04953170045028

MAJ-340 20MM DETACHABLE NYLON LOOP 10/BX

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic ligature loop

• Primary Device ID: 04953170045028
• NIH Device Record Key: d8f92d0e-3b67-4693-9f3a-4c7eba2b7ac6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Loop
• Version Model Number: MAJ-340
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 10
• 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: 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

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	04953170045028 [Primary]
GS1	84953170045024 [Unit of Use]

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

[04953170045028]

Moist Heat or Steam Sterilization

[04953170045028]

Moist Heat or Steam Sterilization

[04953170045028]

Moist Heat or Steam Sterilization

[04953170045028]

Moist Heat or Steam Sterilization

[04953170045028]

Moist Heat or Steam Sterilization

[04953170045028]

Moist Heat or Steam Sterilization

[04953170045028]

Moist Heat or Steam Sterilization

[04953170045028]

Moist Heat or Steam Sterilization

[04953170045028]

Moist Heat or Steam Sterilization

[04953170045028]

Moist Heat or Steam Sterilization

[04953170045028]

Moist Heat or Steam Sterilization

[04953170045028]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Loop]

• 04953170045028: MAJ-340 20MM DETACHABLE NYLON LOOP 10/BX
• 04953170044953: MAJ-254