Single-use Extraction Baskets

GUDID 16971381251675

The single-use extraction baskets is used in combination with the endoscope, entering from the urinary endoscopic channel, passing through the urethra and bladder, entering the ureter, trapping stones and foreign bodies through the basket ring, and then firmly grasping stones and foreign bodies through the basket contraction, and removing stones and foreign bodies.

SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Biliary/urinary stone retrieval basket, single-use

• Primary Device ID: 16971381251675
• NIH Device Record Key: aed5e4ec-afc8-4c93-bc56-38d5d9813132
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use Extraction Baskets
• Version Model Number: EBF-14
• Company DUNS: 544519831
• Company Name: SCIVITA MEDICAL TECHNOLOGY CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	06971381251678 [Primary]
GS1	16971381251675 [Package]; Contains: 06971381251678; Package: [1 Units]; In Commercial Distribution
GS1	26971381251672 [Package]; Package: [36 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-01
• Device Publish Date: 2023-05-24

On-Brand Devices [Single-use Extraction Baskets]

• 16971381251675: The single-use extraction baskets is used in combination with the endoscope, entering from the u
• 16971381251668: The single-use extraction baskets is used in combination with the endoscope, entering from the u
• 16971381251651: The single-use extraction baskets is used in combination with the endoscope, entering from the u
• 06971381251647: The single-use extraction baskets is used in combination with the endoscope, entering from the u