POINT SETTER

GUDID 04048551255902

POINT SETTER, OR-Table Adapter, standard

Karl Storz GmbH & Co. KG

Surgical instrument assist arm system, manually-adjusted

• Primary Device ID: 04048551255902
• NIH Device Record Key: 52d12c7c-8c72-4df9-a2e7-82c29b2bebf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POINT SETTER
• Version Model Number: 28172O
• 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: true
• Serial Number: false
• 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	04048551255902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990334

FDA Product Code

• OCV: Endoscope holder

Sterilization

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

[04048551255902]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-10
• Device Publish Date: 2020-03-02

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