AngioSystems Towel

GUDID 00816611021125

ANGIOSYSTEMS, INCORPORATED

Patient surgical drape, single-use, sterile

• Primary Device ID: 00816611021125
• NIH Device Record Key: 7c6e7dc5-205c-489f-8e55-22511b58c875
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngioSystems Towel
• Version Model Number: 1032-01
• 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	00816611020401 [Primary]
GS1	00816611021125 [Package]; Contains: 00816611020401; Package: [50 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: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-06-15

On-Brand Devices [AngioSystems Towel]

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