Stone basket

GUDID 04059082026084

SOPRO-COMEG GmbH

Bone punch, reusable

• Primary Device ID: 04059082026084
• NIH Device Record Key: ac1ccd64-fbb4-4eb6-b845-3b969b3c76f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stone basket
• Version Model Number: 395 400 100
• Company DUNS: 507185952
• Company Name: SOPRO-COMEG GmbH
• 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: false
• 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	04059082026084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970489

FDA Product Code

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

Sterilization

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

[04059082026084]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [Stone basket]

• 04059082031866: 395 400 101
• 04059082031859: 395 400 100
• 04059082026091: 395 400 101
• 04059082026084: 395 400 100