FDA.reportPublic FDA data

Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX

Primary DI
03701354402201
Brand
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX
Company
PLASMABIOTICS
Model
PW C-G-D 90
Device description
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 series
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
03701354402201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701354402201037013544022013701354402201

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear electrode array introducer, reusableA non-sterile, hand-held manual surgical instrument designed to aid insertion of an electrode array into the cochlea during implantation of a cochlear implant. It is typically a thin probe with a clawed distal end mounted on a handle and is made of high-grade stainless steel. This is a reusable device intended to be sterilized prior to use.

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

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