BONASTENT® Tracheal/Bronchial

Primary DI
08806369422796
Brand
BONASTENT® Tracheal/Bronchial
Company
Sewoon Medical Co., Ltd.
Model
BTB-062012
Published
2021-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JCTProsthesis, Tracheal, Expandable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCTProsthesis, Tracheal, ExpandableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140472000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140472000BONASTENT TRACHEAL / BRONCHIALEndochoice, Inc.2014-10-17JCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806369422796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806369422796088063694227968806369422796

GMDN Terms#

Term, Definition table
TermDefinition
Polymer-metal tracheal/bronchial stentA non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. It is made of both metallic and synthetic polymer materials (e.g., metal mesh with a polymeric cover/lining, or polymeric tubular body with metallic support structures), and may have a straight or branched configuration. 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

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08806369427418BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200L(4.8)S2023-07-27
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08806369427494BAROVAC® Evacuator Closed Wound Drainage System(SS)PS400L(4.8)S2023-07-27
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08806369427654BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400L(4.8)N2732023-07-27
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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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