Loop

GUDID 04953170045028

MAJ-340 20MM DETACHABLE NYLON LOOP 10/BX

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop 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