Hand Controller Sheath AVA 500 HCS

GUDID 10616258005345

Avanta Single Use Hand Controller Sheath (ANGIO-AVANTA,SHEATH,HAND CONTROLLER,MC) (60729466)

BAYER MEDICAL CARE INC.

Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile

• Primary Device ID: 10616258005345
• NIH Device Record Key: 7f9d971e-158f-402a-927f-2ac399bb349b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hand Controller Sheath
• Version Model Number: AVA 500 HCS
• Catalog Number: AVA 500 HCS
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258005348 [Primary]
GS1	10616258005345 [Package]; Contains: 00616258005348; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050456

FDA Product Code

• DXT: Injector And Syringe, Angiographic

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: 2016-09-24

On-Brand Devices [Hand Controller Sheath]

• 10616258007547: Avanta Single Use Hand Controller Sheath (ANGIO-AVANTA,SHEATH,HAND CONTROLLER,MC) (60729652)
• 10616258005345: Avanta Single Use Hand Controller Sheath (ANGIO-AVANTA,SHEATH,HAND CONTROLLER,MC) (60729466)