n.a, 091279-06

GUDID 04048551480854

Video Uretero-Renoscope FLEX-XC1

Karl Storz GmbH & Co. KG

Flexible video ureterorenoscope, single-use

• Primary Device ID: 04048551480854
• NIH Device Record Key: c98a47f4-4ea3-4c9a-a70c-429af0413194
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: n.a,
• Version Model Number: 091279-06
• Catalog Number: 091279-06
• Company DUNS: 315731430
• Company Name: Karl Storz GmbH & Co. KG
• Device Count: 6
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048551428030 [Primary]
GS1	04048551480854 [Unit of Use]

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

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: 2024-12-09
• Device Publish Date: 2024-11-29

Devices Manufactured by Karl Storz GmbH & Co. KG

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• 04048551425695 - n.a.: 2024-12-30 Power LED RUBINA, OPAL1 NIR/ICG
• 04048551107904 - n.a.: 2024-12-23 Guide Wire, Ø 0.9 mm, pkg. of 6
• 04048551360460 - n.a.: 2024-12-23 Nitinol Guide Wire Ø 1.1 mm, 38.5 cm
• 04048551360484 - n.a.: 2024-12-23 Nitinol Guide Wire Ø 2 mm, 38.5 cm
• 04048551364437 - n.a.: 2024-12-23 Guide Sleeve, short, 10.5 cm
• 04048551364444 - n.a.: 2024-12-23 Guide Sleeve, long, 14.5 cm
• 04048551415320 - n.a.: 2024-12-20 KARL STORZ AIDA