ROTOCUT

GUDID 04048551271674

Sealing cap, Package of 5 pcs

Karl Storz GmbH & Co. KG

Laparoscopic access cannula seal, single-use

• Primary Device ID: 04048551271674
• NIH Device Record Key: 10500c67-7532-4558-a993-143fa86ff3ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROTOCUT
• Version Model Number: 26713033
• Company DUNS: 315731430
• Company Name: Karl Storz GmbH & Co. KG
• Device Count: 5
• 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	04048551271667 [Unit of Use]
GS1	04048551271674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061180

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

[04048551271674]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-25
• Device Publish Date: 2016-09-23

Devices Manufactured by Karl Storz GmbH & Co. KG

• 04048438000366 - n.a.: 2024-07-25 Trocar Valve
• 04048551051962 - n.a.: 2024-07-25 Silicone Leaflet Valve
• 04048551070710 - Morcellator: 2024-07-25 Seal Cap, diameter 15 mm
• 04048551071014 - Morcellator: 2024-07-25 Seal Cap, diameter 12 mm
• 04048551071267 - n.a.: 2024-07-25 Sealing Cap
• 04048551116807 - n.a.: 2024-07-25 Sealing Cap, black, 5x
• 04048551116814 - n.a.: 2024-07-25 Sealing Cap, green, 5x
• 04048551271674 - ROTOCUT: 2024-07-25Sealing cap, Package of 5 pcs
• 04048551271674 - ROTOCUT: 2024-07-25 Sealing cap, Package of 5 pcs