AngioSystems Sharp Cup

GUDID 00816611020050

ANGIOSYSTEMS, INCORPORATED

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• Primary Device ID: 00816611020050
• NIH Device Record Key: 6c99adb1-f6b7-4a24-862e-978ec9657eea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngioSystems Sharp Cup
• Version Model Number: 1036
• Company DUNS: 144884467
• Company Name: ANGIOSYSTEMS, INCORPORATED
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816611020029 [Primary]
GS1	00816611020050 [Package]; Contains: 00816611020029; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843260

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-15

Devices Manufactured by ANGIOSYSTEMS, INCORPORATED

• 00816611025871 - AngioSystems Tray: 2023-12-05
• 00816611025895 - AngioSystems Tray: 2023-12-05
• 00816611025819 - AngioSystems Tray: 2022-08-31
• 00816611025833 - AngioSystems Tray: 2022-08-31
• 00816611025802 - AngioSystems Drape: 2022-06-01
• 00816611029992 - AngioSystems Tray: 2022-04-08
• 10816611025755 - AngioSystems Tray: 2022-01-28
• 00816611025741 - AngioSystems Tray: 2022-01-27