D3-LINK

GUDID 04048551379103

IMAGE 1 D3-LINK US

Karl Storz GmbH & Co. KG

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 04048551379103
• NIH Device Record Key: 8b49a00c-f3ac-4f74-a279-302774b72930
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D3-LINK
• Version Model Number: TC302US
• Company DUNS: 315731430
• Company Name: Karl Storz GmbH & Co. KG
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	04048551379103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131953

FDA Product Code

• FET: Endoscopic video imaging system/component, gastroenterology-urology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-19
• Device Publish Date: 2016-09-23

Devices Manufactured by Karl Storz GmbH & Co. KG

• 04048438000984 - n.a.: 2024-03-19 Patient Tubing Set, for day sets
• 04048438001042 - n.a.: 2024-03-19 Tubing Set, UNIDRIVE/UNIDRIVE SIII
• 04048438001233 - n.a.: 2024-03-19 Gas filter, gas flow 30 l/min
• 04048438002230 - n.a.: 2024-03-19 Tubing Set, CLEARVISION II (irrigation)
• 04048438002964 - n.a.: 2024-03-19 Tubing Set, ARTHROPUMP Power(irrigation)
• 04048438003176 - n.a.: 2024-03-19 Pump Tubing Day Set
• 04048438005316 - n.a.: 2024-03-19 Insufflation Tubing Set, with gas filter
• 04048438005330 - n.a.: 2024-03-19 Insufflation tubing set, ENDOFLATOR 50