DEVICE: SYSTEM 83 PLUS (SYSTEM83PLUS9)
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Device Identifier (DI) Information
SYSTEM 83 PLUS
SYSTEM 83 PLUS 9
Not in Commercial Distribution
Wassenburg Medical, Inc.
SYSTEM 83 PLUS 9
Not 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? |
|---|---|---|---|---|
| 66649 | Endoscope washer-disinfector (chemical) |
An electrically-powered unit intended to be used for both washing and chemical disinfection of endoscopes, and their accessories. It has built-in features to circulate cleaning and disinfectant solutions through the lumen (flushing) of the endoscope; some types may also have built-in drying features. It is not intended for device sterilization.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FEB | Accessories, Cleaning, For Endoscope |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| 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 |
|---|
| No Device Sizes |
Device Record Status
1fa36d32-dec9-4598-a194-01f170a4241d
March 19, 2025
6
September 25, 2016
March 19, 2025
6
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 | Not in Commercial Distribution | Corrugate Box |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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