FDA.report

n.a.

Primary DI
04048551067574
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
20400028
Device description
CO2 High Pressure Tube, Pin-Index
Published
2019-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NKCTubing/tubing with filter, insufflation, laparoscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551067574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551067574040485510675744048551067574

GMDN Terms

TermDefinition
High-pressure medical gas hoseA length of flexible tube intended to deliver and withstand gases under very high pressure, e.g., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials (e.g., plastic, rubber, or nylon), and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315731430
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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