FDA.reportPublic FDA data

SYSTEM 83 PLUS

Primary DI
G434SYSTEM83PLUS2
Brand
SYSTEM 83 PLUS
Company
Wassenburg Medical, Inc.
Model
SYSTEM 83 PLUS 2
Device description
A device to disinfect endoscopes
Published
2023-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEBAccessories, Cleaning, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEBAccessories, Cleaning, For EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G434SYSTEM83PLUS2PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument non-thermal chemical disinfectorAn electrically-powered unit intended to be used for the non-thermal chemical disinfection of probes, surgical instruments, and/or endoscopes, and their accessories (e.g., heat-sensitive instruments). It may include washing features and may have built-in features to circulate cleaning and disinfectant solutions through a device lumen; some types may also have built-in drying features. It is not intended for device sterilization.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Do not fork lift
Special Storage Condition, Specify00Fragile
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
215-364-1477info@wassenburgmedical.com

Regulatory Flags#

DUNS number
118762097
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
SYSTEM83PLUS9SYSTEM 83 PLUSSYSTEM 83 PLUS 92016-09-25
00860010835241System 83 RevolveSystem 83 Revolve2025-02-24
00860010835210Scope Assist Flushing Sink (SAFS)S62024-04-23
00860010835227Scope Assist Flushing Sink (SAFS)S82024-04-23
G434FLUSHINGSINKMODELS6Scope Assist Flushing Sink (SAFS)S62023-08-11
G434FLUSHINGSINKMODELS8Scope Assist Flushing Sink (SAFS)S82023-08-11
G434SYSTEM83PLUS9SYSTEM 83 PLUSSYSTEM 83 PLUS 92023-08-11
SYSTEM83PLUS2SYSTEM 83 PLUSSYSTEM 83 PLUS 22016-09-25
FLUSHINGSINKMODELS6Scope Assist Flushing Sink (SAFS)S62017-05-16
FLUSHINGSINKMODELS8Scope Assist Flushing Sink (SAFS)S82017-05-16
00860010835265Wassenburg Transport Cart TC-6TC-62024-04-23
STORAGECABINET20000Storage Cabinet200002021-09-07
DRY320DRY320DRY3202023-10-31
G434SC200001Storage Cabinet20000E001882023-07-27
00860010835203Storage Cabinet200002024-04-23
00860010835234DRY320DRY3202024-04-23
G434DRY320DRY320DRY3202023-10-31
G434TC61Wassenburg® Transport Cart TC-6TC-62023-07-06
PPS83S6Pre-Processing Sink83-S62017-10-31
PPS83S8Pre-Processing Sink83-S8 2017-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995245962Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
10724995245969Rapicide PA High-Level DisinfectantMEDIVATORS INC.FEB2026-03-06
00724995244392NASTERIS CORPORATIONFEB2025-10-21
00724995355470NASTERIS CORPORATIONFEB2025-10-21
00724995355487NASTERIS CORPORATIONFEB2025-10-21
40677964055322Medivators HookupMEDIVATORS INC.FEB2025-06-10
40677964054448Medivators HookupMEDIVATORS INC.FEB2025-04-04
40677964054622Medivators HookupMEDIVATORS INC.FEB2025-04-04
00860010835241System 83 RevolveWassenburg Medical, Inc.FEB2025-02-24
04260306710577SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
04260306710584SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
10705037069316EVOTECH™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FEB2024-06-20
00724995225209NASTERIS CORPORATIONFEB2024-06-03
00724995225216NASTERIS CORPORATIONFEB2024-06-03
00724995225223NASTERIS CORPORATIONFEB2024-06-03
00724995225230NASTERIS CORPORATIONFEB2024-06-03
00724995225247NASTERIS CORPORATIONFEB2024-06-03
00724995225254NASTERIS CORPORATIONFEB2024-06-03
00724995225261NASTERIS CORPORATIONFEB2024-06-03
00724995225278NASTERIS CORPORATIONFEB2024-06-03
00724995225285NASTERIS CORPORATIONFEB2024-06-03
00724995225292NASTERIS CORPORATIONFEB2024-06-03
00724995225308NASTERIS CORPORATIONFEB2024-06-03
00724995225315NASTERIS CORPORATIONFEB2024-06-03
00724995225322NASTERIS CORPORATIONFEB2024-06-03
00724995225339NASTERIS CORPORATIONFEB2024-06-03
00724995225346NASTERIS CORPORATIONFEB2024-06-03
00724995225353NASTERIS CORPORATIONFEB2024-06-03
00724995225360NASTERIS CORPORATIONFEB2024-06-03
00724995225377NASTERIS CORPORATIONFEB2024-06-03