FDA.reportPublic FDA data

SURGISTAIN (4.2oz/125ml bottle)

Primary DI
00810929015036
Brand
SURGISTAIN (4.2oz/125ml bottle)
Company
Ruhof Corporation
Model
34572-08
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

Product Codes#

Code, Name table
CodeName
FLGCleaner, Ultrasonic, Medical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810929015036PackageGS1100In Commercial Distribution
00810929015029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810929015036008109290150368109290150360810929015036
00810929015029008109290150298109290150290810929015029

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature40 Degrees Fahrenheit130 Degrees Fahrenheit
Storage Environment Temperature40 Degrees Fahrenheit130 Degrees Fahrenheit

Sterilization Methods#

Method table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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