DEVICE: SYSTEM 83 PLUS (SYSTEM83PLUS9)
Device Identifier (DI) Information
SYSTEM 83 PLUS
SYSTEM 83 PLUS 9
In Commercial Distribution
Wassenburg Medical, Inc.
SYSTEM 83 PLUS 9
In Commercial Distribution
Wassenburg Medical, Inc.
A device to disinfect endoscopes
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35012 | Endoscope washer/disinfector |
A mains electricity (AC-powered) unit intended to be used for the washing and/or disinfecting of endoscopes, and their accessories, with water or an appropriate disinfectant solution. It has built-in features to circulate a solution through the lumen (flushing) of the endoscope; some types may also have built-in drying features.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FEB | Accessories, Cleaning, For Endoscope |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep Dry |
Handling Environment Temperature: between 0 and 60 Degrees Celsius |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify: Do not fork lift |
Special Storage Condition, Specify: Fragile |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1fa36d32-dec9-4598-a194-01f170a4241d
July 03, 2023
5
September 25, 2016
July 03, 2023
5
September 25, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B21583PLUS9 | 1 | SYSTEM83PLUS9 | In Commercial Distribution | Corrugate Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
215-364-1477
info@customultrasonics.com
info@customultrasonics.com