SB Soft Hood /Straight type

Primary DI
04545499068880
Brand
SB Soft Hood /Straight type
Company
SB-KAWASUMI LABORATORIES, INC.
Model
MD-47960
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
24545499068884PackageGS15In Commercial Distribution
04545499068880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2454549906888424545499068884
04545499068880045454990688804545499068880

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04545499074423SB Knife Jr2MD-477022026-04-06
04545499074430SB Knife Jr2 /Long typeMD-47702L2026-04-06
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
00646311410055SMALL VEIN INFUSION SETD3K2-19GD3K2-19G2016-09-20
00646311410062SMALL VEIN INFUSION SETD3K2-20GD3K2-20G2016-09-20
00646311410079SMALL VEIN INFUSION SETD3K2-21GD3K2-21G2016-09-20
00646311410086SMALL VEIN INFUSION SETD3K2-22GD3K2-22G2016-09-20
00646311410093SMALL VEIN INFUSION SETD3K2-23GD3K2-23G2016-09-20
00646311410109SMALL VEIN INFUSION SETD3K2-24GD3K2-24G2016-09-20
00646311410116SMALL VEIN INFUSION SETD3K2-25GD3K2-25G2016-09-20
00646311410123SMALL VEIN INFUSION SETD3K2-27GD3K2-27G2016-09-20
00646311410482K-SHIELD ADVANTAGE SMALL VEIN INFUSION SETD3KA-19GD3KA-19G2016-09-20
00646311410505K-SHIELD ADVANTAGE SMALL VEIN INFUSION SETD3KA-27GD3KA-27G2016-09-20
04987488104139K-Shield Advantage Blood Drawing KitBK-64ABK-64A2024-12-24
04987488104146INTERMITTENT INJECTION SITEINT-01INT-012024-12-06

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