FDA.reportPublic FDA data

Silicone connection set for cystoscopes and ureteroscopes WOLF, STORZ, OLYMPUS,

Primary DI
03701354403000
Brand
Silicone connection set for cystoscopes and ureteroscopes WOLF, STORZ, OLYMPUS,
Company
PLASMABIOTICS
Model
Wol U
Device description
Silicone connection set for cystoscopes and ureteroscopes WOLF, STORZ, OLYMPUS, PENTAX with two luer-lock channel entrances
Published
2021-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701354403000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701354403000037013544030003701354403000

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope clean-storage systemA mobile, mains electricity (AC-powered) assembly of devices intended to prepare, bag, label and register disinfected and sterilized endoscopes prior to long-term storage. It typically includes: 1) a fluid preparation assembly such as fluid pump, tubing and a preparation solution (e.g., hydrogen peroxide solution); 2) devices intended to achieve sealed-storage such as trays, sterile liners, vacuum bags, and a vacuum pump; 3) labelling/registration devices (i.e., bar-code printer and bar-code reader); and 4) a computer with integrated software for process/data management. It is not intended to clean, disinfect or sterilize but to maintain the sterilized/disinfected state of the endoscope.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3Centimeter
Length34Centimeter
Width23Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure0.9 Inches of Mercury1.1 Inches of Mercury
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262972663
Device count
1
Premarket exempt
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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03701354404502Thermal transfer ribbon 74 m for TSC printerFterm2021-05-14
03701354404601Self-adhesive bar-code, 10 unitsCBar-AC2021-05-14
03701354404700Coplex bar-code (to attach), 10 unitsCBar-CP2021-05-14
03701354404809Stainless steel bar-code (to attach), 10 unitsCBar-IN2021-05-14
03701354404908Demo Flight caseFCD-Typhoon2021-05-14
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03701354405110Autoclavable version of PP EEB-J10PP EEB-J10/A2021-05-14
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03701354405417Autoclavable version of Oly COly C/A2021-05-14
03701354406704Polyurethane tube, int. diam. 4 mm, ext. diam. 6 mm, length 30 mTPU6-PT2021-05-14
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