FDA.report

SURGISTAIN (4 Liter FB63)

Primary DI
10810929045191
Brand
SURGISTAIN (4 Liter FB63)
Company
Ruhof Corporation
Model
34572-32
Device description
Enzymatic detergents used to clean medical instruments.
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FLGCleaner, Ultrasonic, Medical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810929045191PackageGS14In Commercial Distribution
00810929045194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081092904519110810929045191
00810929045194008109290451948109290451940810929045194

GMDN Terms

TermDefinition
Instrument anti-oxidation agentA liquid substance intended to prevent corrosion on the surface of stainless steel medical/surgical instruments (e.g., specula, forceps) through its anti-oxidation properties. It is typically a concentrated phosphoric acid (H3PO4) that is used as specified by the manufacturer in an aqueous solution to treat devices by manual soaking or in an ultrasonic water bath. Also known as an instrument renovating agent, it is intended to remove protein stains, iron oxide deposits, and other oxide stains to prevent rust pitting and help improve instrument longevity. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature40 Degrees Fahrenheit130 Degrees Fahrenheit
Storage Environment Temperature40 Degrees Fahrenheit130 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
082779828
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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10810929045627ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-292025-09-22
00810929011410ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE) 345ESS4F2025-07-11
00810929011281ENDOZIME INSTRUSPONGE 1mm (RIGID)345ESS1R2025-07-10
00810929011298ENDOZIME INSTRUSPONGE 1.5mm (RIGID) 345ESS1.5R2025-07-10
00810929011519ENDOZIME INSTRUSPONGE 1.75mm (RIGID) 345ESS2R2025-07-10
00810929011311ENDOZIME INSTRUSPONGE 3mm (RIGID) 345ESS3R2025-07-10
00810929011526ENDOZIME INSTRUSPONGE 5mm (RIGID) 345ESS5R2025-07-10
00810929011335ENDOZIME INSTRUSPONGE 7mm (RIGID) 345ESS7R2025-07-10
00810929011342ENDOZIME INSTRUSPONGE 10mm (RIGID) 345ESS10R2025-07-10
00810929011359ENDOZIME INSTRUSPONGE 12mm (RIGID) 345ESS12R2025-07-10
00810929011366ENDOZIME INSTRUSPONGE 14mm (RIGID) 345ESS14R2025-07-10
00810929011373ENDOZIME INSTRUSPONGE 1mm (FLEXIBLE) 345ESS1F2025-07-10
00810929011397ENDOZIME INSTRUSPONGE 2mm (FLEXIBLE) 345ESS2F2025-07-10
00810929011403ENDOZIME INSTRUSPONGE 3mm (FLEXIBLE) 345ESS3F2025-07-10
00810929011427ENDOZIME INSTRUSPONGE 5mm (FLEXIBLE) 345ESS5F2025-07-10
00810929017238SCOPEVALET DUAL END VALVE BRUSH345VB2025-07-10
00810929043817Double Head Stubby Valve BrushSB1802025-07-10
00810929043855Push Thru 60 PackSVPT602025-07-10
00810929011380ENDOZIME INSTRUSPONGE 1.5mm (FLEXIBLE) 345ESS1.5F2025-07-07
00810929016804SCOPEVALET ENDO BRUSH (2-4mm)345EBS2025-07-07

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