FD257

GUDID 00724995176730

The RAS 12 Long Rack is designed to enable the mechanical cleaning, rinsing, and disinfection of up to 12 robotic-assisted surgery instruments in the AMSCO 7052HP and or 7053HP Single Chamber Washer Disinfectors.

Corporation Steris Canada

Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack Sterilizer/disinfector rack

• Primary Device ID: 00724995176730
• NIH Device Record Key: 4fd82daf-f1f0-426c-b6b2-3e9a1b1aa766
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: FD257
• Catalog Number: FD257
• Company DUNS: 202659140
• Company Name: Corporation Steris Canada
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995176730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190081

FDA Product Code

• NVE: Washer, cleaner, automated, endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-17
• Device Publish Date: 2019-09-09

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• 00724995217440 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
• 00724995217457 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
• 00724995217464 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
• 00724995217471 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
• 00724995217488 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
• 00724995217495 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
• 00724995217501 - enspire: 2024-04-25 The enspire 3000 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and