SB Soft Hood /Undercut type

Primary DI
04545499068897
Brand
SB Soft Hood /Undercut type
Company
SB-KAWASUMI LABORATORIES, INC.
Model
MD-47961
Device description
The Product is a transparent distal attachment applied to the tip of the endoscope. It is used in ESD procedures. This Product is used for maintaining visualization during the dissection phase of the procedure. This Product contains drainage side hole that allows egress of water and blood. This Product is disposable and in a variety of diameters that correspond to different endoscope sizes.
Published
2018-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDSGastroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24545499068891PackageGS15In Commercial Distribution
04545499068897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2454549906889124545499068891
04545499068897045454990688974545499068897

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope hoodA sterile, Hevea-latex, bell-shaped device designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of a foreign body. The device everts to create a dome around the (sharp) foreign object to protect the wall of the viscus as the endoscope/foreign body is extracted. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter15.3Millimeter

Regulatory Flags#

DUNS number
690625850
Device count
1
Lot or batch
true
Expiration date on label
true

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00646311400018WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-21GDBM1-21G2016-09-20
00646311400025WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-23GDBM1-23G2016-09-20
00646311400032WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-25GDBM1-25G2016-09-20
00646311410017SMALL VEIN INFUSION SETD3K1-21G1D3K1-21G12016-09-20
00646311410024SMALL VEIN INFUSION SETD3K1-23G1D3K1-23G12016-09-20
00646311410031SMALL VEIN INFUSION SETD3K1-25G1D3K1-25G12016-09-20

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