Best Medical International

GUDID 00841365117107

BEST MEDICAL INTERNATIONAL, INC.

Gastrointestinal/biliary dilation balloon catheter

• Primary Device ID: 00841365117107
• NIH Device Record Key: 767a24bc-c9c1-47ab-95ac-89cddddbb074
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Best Medical International
• Version Model Number: 4020-E-S
• Company DUNS: 086352655
• Company Name: BEST MEDICAL INTERNATIONAL, INC.
• Device Count: 1
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841365117107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162499

FDA Product Code

• JAQ: System, Applicator, Radionuclide, Remote-Controlled

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-14
• Device Publish Date: 2019-05-06

On-Brand Devices [Best Medical International]

• 00841365117077: 1175-4
• 00841365117060: 1175-3
• 00841365117084: 2021-1-3
• 00841365117091: 1899-15-4
• 00841365117107: 4020-E-S
• 00841365117121: 1933-15
• 00841365117152: 735-18
• 00841365117145: 259-29.3
• 00841365117138: 1928-25-1
• 00841365117190: 2198-2
• 00841365117183: 1454-1-2
• 00841365117176: 1478-2-S
• 00841365117169: 2201-1
• 00841365117206: 253-35
• 00841365100628: 1354-30-5
• 00841365100611: 1354-25-5
• 00841365100604: 1354-20-5
• 00841365100598: 1354-15-5
• 00841365100581: 1354-10-5
• 00841365117213: 837
• 00841365117220: 253-28.5
• 00841365117268: 2204-25
• 00841365117251: 2204-20
• 00841365117244: 2204-15
• 00841365117237: 1037-10
• 00841365117275: 2197-32
• 00841365117282: 1924-30
• 00841365117305: 1002-0012
• 00841365117299: 1161-30-5
• 00841365117381: 1055-32
• 00841365117404: 356-32
• 00841365117398: 253-32
• 00841365117435: 2082-25-1
• 00841365117428: 1634-29.4-1
• 00841365117411: 1041-29.4
• 00841365117459: 2162-32-4
• 00841365117442: 2162-25.3-4
• 00841365117466: 277-30
• 00841365117473: 2228-15-5
• 00841365117480: 1458-10-5
• 00841365117565: 1658-32-5
• 00841365117558: 1303-32-5
• 00841365117541: 1658-32-3
• 00841365117534: 1658-32-1
• 00841365117527: 1303-32-3
• 00841365117510: 1303-32-1
• 00841365117602: 10215-25
• 00841365117589: 10215-5
• 00841365117572: 10215-1
• 00841365117633: 837-20