FDA.report

SURGISTAIN (8.45oz/250ml bottle)

Primary DI
00810929010246
Brand
SURGISTAIN (8.45oz/250ml bottle)
Company
Ruhof Corporation
Model
34572-10
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
00810929010246PackageGS120In Commercial Distribution
00810929010239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810929010246008109290102468109290102460810929010246
00810929010239008109290102398109290102390810929010239

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

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00810929011373ENDOZIME INSTRUSPONGE 1mm (FLEXIBLE) 345ESS1F2025-07-10
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00810929011403ENDOZIME INSTRUSPONGE 3mm (FLEXIBLE) 345ESS3F2025-07-10
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