FDA.reportPublic FDA data

BONASTENT® Biliary

Primary DI
08806369461504
Brand
BONASTENT® Biliary
Company
Sewoon Medical Co., Ltd.
Model
BB-100918
Published
2017-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGECatheter, Biliary, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140760000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140760000BONASTENT BILIARYEndochoice, Inc.2014-06-16FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806369461504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806369461504088063694615048806369461504

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal biliary stentA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687784405
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806369400220BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200M2+(3.2)2023-07-27
08806369400244BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200L2+(4.8)2023-07-27
08806369427333BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100M(3.2)S2023-07-27
08806369427371BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200M(3.2)S2023-07-27
08806369427418BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200L(4.8)S2023-07-27
08806369427456BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200L+(4.8)S2023-07-27
08806369427494BAROVAC® Evacuator Closed Wound Drainage System(SS)PS400L(4.8)S2023-07-27
08806369427616BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400M(3.2)N2732023-07-27
08806369427654BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400L(4.8)N2732023-07-27
08806369427692BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400S(2.4)2023-07-27
08806369427739BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400M(3.2)S2023-07-27
08806369427777BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400L(4.8)S2023-07-27
08806369452007BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100M(3.2)2023-07-27
08806369452021BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100M+(3.2)2023-07-27
08806369452045BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100L(4.8)2023-07-27
08806369452069BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100L+(4.8)2023-07-27
08806369452083BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100LD(4.8)2023-07-27
08806369452106BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100JP(4.8)2023-07-27
08806369452120BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100M2(3.2)2023-07-27
08806369452526BAROVAC® Evacuator Closed Wound Drainage System(SS)SS150M+(3.2)2023-07-27

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Primary DI, Brand, Company table
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