FDA.reportPublic FDA data

BONASTENT® Esophageal

Primary DI
08806369459044
Brand
BONASTENT® Esophageal
Company
Sewoon Medical Co., Ltd.
Model
BE-1810
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
ESWProsthesis, Esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESWProsthesis, EsophagealGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092144000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092144000BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFREndochoice, Inc.2010-02-22ESW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806369459044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806369459044088063694590448806369459044

GMDN Terms#

Term, Definition table
TermDefinition
Polymer-metal oesophageal stent, sterileA sterile, non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other lesions causing oesophageal leakage (e.g. anastomotic). It consists of a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., 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
Contains natural rubber latex
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800026631149HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-29
00884450093580RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093597RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093603RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093627RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450093917RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094020RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094037RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094105RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
00884450094242RESILIENCE™Merit Medical Systems, Inc.ESW2026-01-24
08800026612711HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612728HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612735HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612742HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612759HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612766HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612773HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026612780HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22
08800026631156HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631163HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631170HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631187HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631194HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631200HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631217HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631224HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631231HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631286HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631293HILZO Esophageal stentsBCM Co., Ltd.ESW2026-01-22
08800026631989HILZO Esophageal stents BCM Co., Ltd.ESW2026-01-22