AngioSystems Tray

GUDID 00816611023419

ANGIOSYSTEMS, INCORPORATED

General surgical procedure kit, medicated

• Primary Device ID: 00816611023419
• NIH Device Record Key: d1b27bbc-dc9e-4f1a-9b63-4ab7582ba136
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngioSystems Tray
• Version Model Number: 5049
• 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	00816611023402 [Primary]
GS1	00816611023419 [Package]; Contains: 00816611023402; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905462

FDA Product Code

• LRP: Tray, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-01
• Device Publish Date: 2018-08-29

On-Brand Devices [AngioSystems Tray]

• 00816611025147: KM5067
• 00816611025123: KM5066
• 00816611025062: KM5065
• 00816611025048: KM5064
• 00816611024782: 43545-3
• 00816611024768: 1056
• 00816611024744: 1055
• 00816611024720: 1036
• 00816611024706: 1015
• 00816611024683: 1002-2
• 00816611024669: 1000
• 00816611024645: KM5063
• 00816611024621: KM5062
• 00816611024607: KM5061
• 00816611024584: KM5059
• 00816611024560: KM5058
• 00816611024546: KM5057
• 00816611024522: KM5056
• 00816611024508: KM5055
• 00816611024485: KM5054
• 00816611024461: KM5052
• 00816611024447: KM5050
• 00816611024423: KM5045
• 00816611024409: KM5044
• 00816611024386: KM5043
• 00816611024362: KM5042
• 00816611024348: KM5035
• 00816611024324: KM5034
• 00816611024300: KM5032
• 00816611024287: KM5031
• 00816611024263: KM5030
• 00816611024249: KM5029
• 00816611024225: KM5028
• 00816611024201: KM5025
• 00816611024188: KM5024
• 00816611024164: KM5023
• 00816611024140: KM5022
• 00816611024126: KM5021
• 00816611024102: KM5020
• 00816611024089: KM5017
• 00816611024065: KM5014
• 00816611024041: KM5009
• 00816611024027: 5680-11
• 00816611024003: 5125
• 00816611023983: 5120
• 00816611023969: 5800
• 00816611023945: 5744
• 00816611023921: 5743
• 00816611023907: 5742
• 00816611023884: 5732