SB Soft Hood™ MD-47961

GUDID 24545499068891

SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is used in endoscopic submucosal dissection (hereinafter ESD)

SUMITOMO BAKELITE COMPANY LIMITED

Endoscope hood
Primary Device ID24545499068891
NIH Device Record Key5b1e7b3d-cdf6-4ae1-9078-69ed5b74179a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSB Soft Hood™
Version Model NumberUndercut Type
Catalog NumberMD-47961
Company DUNS690551106
Company NameSUMITOMO BAKELITE COMPANY LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter15.3 Millimeter
Outer Diameter15.3 Millimeter
Outer Diameter15.3 Millimeter
Outer Diameter15.3 Millimeter
Outer Diameter15.3 Millimeter
Outer Diameter15.3 Millimeter
Outer Diameter15.3 Millimeter
Outer Diameter15.3 Millimeter
Outer Diameter15.3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104545499068897 [Primary]
GS124545499068891 [Package]
Contains: 04545499068897
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDSGastroscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-31
Device Publish Date2018-09-30

On-Brand Devices [SB Soft Hood™]

24545499068914SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use
24545499068907SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use
24545499068891SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use
24545499068884SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use
24545499068877SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use
24545499068860SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use

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