LIGATING DEVICE

GUDID 14953170044929

HX-20U-1.B DETACH LOOP 2.8MM CHAN 230CM

OLYMPUS MEDICAL SYSTEMS CORP.

Polypectomy endoscopic ligator, reusable

• Primary Device ID: 14953170044929
• NIH Device Record Key: aa800aeb-2a16-4aea-803a-866c0b729826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIGATING DEVICE
• Version Model Number: HX-20U-1
• 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: 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	04953170044922 [Primary]
GS1	14953170044929 [Package]; Contains: 04953170044922; Package: [1 Units]; In Commercial Distribution

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

[14953170044929]

Moist Heat or Steam Sterilization

[14953170044929]

Moist Heat or Steam Sterilization

[14953170044929]

Moist Heat or Steam Sterilization

[14953170044929]

Moist Heat or Steam Sterilization

[14953170044929]

Moist Heat or Steam Sterilization

[14953170044929]

Moist Heat or Steam Sterilization

[14953170044929]

Moist Heat or Steam Sterilization

[14953170044929]

Moist Heat or Steam Sterilization

[14953170044929]

Moist Heat or Steam Sterilization

[14953170044929]

Moist Heat or Steam Sterilization

[14953170044929]

Moist Heat or Steam Sterilization

[14953170044929]

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 [LIGATING DEVICE]

• 14953170044929: HX-20U-1.B DETACH LOOP 2.8MM CHAN 230CM
• 14953170044868: HX-20Q-1