Nitinol Stone Extractor, helical basket, 4 wires, 2.5 Fr ROSH2500ST

GUDID 03700512986256

Promepla

Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use

• Primary Device ID: 03700512986256
• NIH Device Record Key: 9522ea2c-8a6b-4741-8cd5-2bf1db6fd7c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nitinol Stone Extractor, helical basket, 4 wires, 2.5 Fr
• Version Model Number: 09-0021
• Catalog Number: ROSH2500ST
• Company DUNS: 401020409
• Company Name: Promepla
• 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: 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: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700512966258 [Primary]
GS1	03700512976257 [Package]; Contains: 03700512966258; Package: Box [1 Units]; In Commercial Distribution
GS1	03700512986256 [Package]; Contains: 03700512976257; Package: Box [4 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-11-09

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