AngioSystems Towel

GUDID 00816611021064

ANGIOSYSTEMS, INCORPORATED

Angiographic drape

• Primary Device ID: 00816611021064
• NIH Device Record Key: 93991b16-7401-4516-bc4f-b4a147e3af52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngioSystems Towel
• Version Model Number: SB017026
• Company DUNS: 144884467
• Company Name: ANGIOSYSTEMS, INCORPORATED
• Device Count: 250
• 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	00816611021019 [Unit of Use]
GS1	00816611021064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843260

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

[00816611021064]

Ethylene Oxide

[00816611021064]

Ethylene Oxide

[00816611021064]

Ethylene Oxide

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

On-Brand Devices [AngioSystems Towel]

• 00816611021064: SB017026
• 00816611021125: 1032-01
• 00816611021118: 1002-2