Accordion CoAx Stone Control Device PA1305-01-15

GUDID 00857252004009

Accordion CoAx Stone Control Device

T H S INTERNATIONAL, INC.

Ureteropelvic stone filtering catheter

• Primary Device ID: 00857252004009
• NIH Device Record Key: 257afcef-86ba-4218-825f-e25ed928d969
• Commercial Distribution Discontinuation: 2020-01-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Accordion CoAx Stone Control Device
• Version Model Number: PA1305-01-15
• Catalog Number: PA1305-01-15
• Company DUNS: 101084796
• Company Name: T H S 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: false
• Expiration Date: true
• 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: 317-759-2869
• Email: sales@accordionmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857252004009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082803

FDA Product Code

• FFL: Dislodger, Stone, Basket, Ureteral, Metal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-27
• Device Publish Date: 2016-06-06

Devices Manufactured by T H S INTERNATIONAL, INC.

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• 00857252004023 - Accordion Stone Management Device: 2020-01-27 Accordion Stone Management Device
• 00857252004030 - Accordion Piccolo Stone Management Device: 2020-01-27 Accordion Piccolo Stone Management Device