FDA.reportPublic FDA data

SB Soft Hood™

Primary DI
24545499068907
Brand
SB Soft Hood™
Company
SUMITOMO BAKELITE COMPANY LIMITED
Model
Straight Type
Catalog number
MD-47970
Device description
SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is used in endoscopic submucosal dissection (hereinafter ESD)
Published
2018-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173004000SB Soft Hood - Straight type, SB Soft Hood - Undercut typeSumitomo Bakelite Co., Ltd.2018-05-08FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24545499068907PackageGS15In Commercial Distribution
04545499068903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2454549906890724545499068907
04545499068903045454990689034545499068903

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 Diameter16.2Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690551106
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
24545499071693Tentacles NEOMD-27320A2019-11-15
24545499070832Tentacles NEOMD-273202019-11-15
24545499064664SB Knife™Jr TypeMD-47703W2016-09-12
24545499064671SB Knife™Jr Type - LongMD-47703L2016-09-12
24545499064688SB Knife™Short TypeMD-477042016-09-12
24545499064695SB Knife™Standard TypeMD-477062016-09-12
24545499068860SB Soft Hood™Straight TypeMD-479502018-09-30
24545499068877SB Soft Hood™Undercut TypeMD-479512018-09-30
24545499068884SB Soft Hood™Straight TypeMD-479602018-09-30
24545499068891SB Soft Hood™Undercut TypeMD-479612018-09-30
24545499068914SB Soft Hood™Undercut TypeMD-479712018-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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