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
Primary Device ID00724995176730
NIH Device Record Key4fd82daf-f1f0-426c-b6b2-3e9a1b1aa766
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberFD257
Catalog NumberFD257
Company DUNS202659140
Company NameCorporation Steris Canada
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)548-4873
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Phone+1(800)548-4873
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Phone+1(800)548-4873
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Phone+1(800)548-4873
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Phone+1(800)548-4873
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Phone+1(800)548-4873
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Phone+1(800)548-4873
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Phone+1(800)548-4873
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Phone+1(800)548-4873
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Phone+1(800)548-4873
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Device Identifiers

Device Issuing AgencyDevice ID
GS100724995176730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVEWasher, cleaner, automated, endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-17
Device Publish Date2019-09-09

Devices Manufactured by Corporation Steris Canada

00724995224905 - NA2024-12-03 FUJIFILM 580 SERIES ERCP ENDOSCOPE TUBING AND CONNECTOR
00724995224912 - NA2024-12-03 FUJIFILM EB-580S BRONCHOSCOPE TUBING AND CONNECTOR
00724995217433 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217440 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217457 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217464 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217471 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217488 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a

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