AngioSystems Drape

GUDID 00816611021477

ANGIOSYSTEMS, INCORPORATED

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• Primary Device ID: 00816611021477
• NIH Device Record Key: 78f6dda7-e57f-4e8e-a013-bd1e065d5c75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngioSystems Drape
• Version Model Number: 3427
• 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	00816611020203 [Primary]
GS1	00816611021477 [Package]; Contains: 00816611020203; Package: [20 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 Drape]

• 0081661102191: 9260-12
• 00816611025109: 3631-10
• 00816611025000: 3606-1
• 00816611022993: 5520
• 00816611022955: 5073
• 00816611022931: 5061
• 00816611022917: 5020
• 00816611022894: 3425-10
• 00816611022870: 9266
• 00816611022856: 9265-1
• 00816611022832: 3671
• 00816611022818: 3528
• 00816611021972: 3060-08
• 00816611021958: RS1000
• 00816611021941: ASD2111
• 00816611021897: 9009-01NS
• 00816611021873: 3606
• 00816611021859: DR5-18063NS
• 00816611021842: ASD3330-1
• 00816611021835: 9360NS
• 00816611021804: 9229-03NS
• 00816611021781: 9061NS
• 00816611021576: 3606NS
• 00816611021538: 3434NS
• 00816611021460: 3422NS
• 00816611021446: 3400NS
• 00816611021439: 3241NS
• 00816611021422: 3236NS
• 00816611021415: 3215NS
• 00816611021262: 3003-45NS
• 00816611021149: 3001NS
• 00816611021132: 060-1722A
• 00816611021101: KBD0231
• 00816611021095: 060-1711A
• 00816611021071: KBD2545-4NS
• 00816611020999: KBD0700
• 00816611021828: 9260-15
• 00816611021811: 9260-10
• 00816611021798: 9228-1
• 00816611021767: 9009-01
• 00816611021712: 3904-10
• 00816611021705: 3902-1
• 00816611021675: 3665-1
• 00816611021668: 3663-01
• 00816611021644: 3648-03
• 00816611021620: 3631-03
• 00816611021606: 3627-01
• 00816611021590: 3616-03
• 00816611021583: 3609-01
• 00816611021514: 3432-02S