Nitinol Stone Extractor, TIPLESS basket 4 wires, 1.3 Fr ROSZ1300ST

GUDID 03700512986270

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: 03700512986270
• NIH Device Record Key: 9200084d-26f7-44cd-ad91-a0e6fdb196db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nitinol Stone Extractor, TIPLESS basket 4 wires, 1.3 Fr
• Version Model Number: 09-0023
• Catalog Number: ROSZ1300ST
• 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	03700512966272 [Primary]
GS1	03700512976271 [Package]; Contains: 03700512966272; Package: Box [1 Units]; In Commercial Distribution
GS1	03700512986270 [Package]; Contains: 03700512976271; 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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• 03700512987505 - LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.24cm, without wire: 2024-01-15
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