FDA.reportPublic FDA data

PREMIXSLIP (4.2oz/125ml with mister)

Primary DI
00810929010369
Brand
PREMIXSLIP (4.2oz/125ml with mister)
Company
Ruhof Corporation
Model
34552-09
Device description
Lubricant for medical Instrument
Published
2025-06-24
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
00810929010369PackageGS1100In Commercial Distribution
00810929010352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810929010369008109290103698109290103690810929010369
00810929010352008109290103528109290103520810929010352

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument maintenance lubricantA non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. 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
true
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
00810929045637Liquizime XP (4 Liter RB53)54323-312025-10-17
00810929045644Endozime Premium XP (4 Liter RB53)54324-312025-10-17
00810929045620ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-292025-09-22
10810929045627ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-292025-09-22
00810929045613ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-302025-06-17
00810929010147ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE) 345ESS4F2025-07-11
00810929011410ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE) 345ESS4F2025-07-11
00810929010017ENDOZIME INSTRUSPONGE 1mm (RIGID)345ESS1R2025-07-10
00810929010024ENDOZIME INSTRUSPONGE 1.5mm (RIGID) 345ESS1.5R2025-07-10
00810929010031ENDOZIME INSTRUSPONGE 1.75mm (RIGID) 345ESS2R2025-07-10
00810929010048ENDOZIME INSTRUSPONGE 3mm (RIGID) 345ESS3R2025-07-10
00810929010055ENDOZIME INSTRUSPONGE 5mm (RIGID) 345ESS5R2025-07-10
00810929010062ENDOZIME INSTRUSPONGE 7mm (RIGID) 345ESS7R2025-07-10
00810929010079ENDOZIME INSTRUSPONGE 10mm (RIGID) 345ESS10R2025-07-10
00810929010086ENDOZIME INSTRUSPONGE 12mm (RIGID) 345ESS12R2025-07-10
00810929010093ENDOZIME INSTRUSPONGE 14mm (RIGID) 345ESS14R2025-07-10
00810929010109ENDOZIME INSTRUSPONGE 1mm (FLEXIBLE) 345ESS1F2025-07-10
00810929010123ENDOZIME INSTRUSPONGE 2mm (FLEXIBLE) 345ESS2F2025-07-10
00810929010130ENDOZIME INSTRUSPONGE 3mm (FLEXIBLE) 345ESS3F2025-07-10
00810929010154ENDOZIME INSTRUSPONGE 5mm (FLEXIBLE) 345ESS5F2025-07-10

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