Tiche PTA Balloon Dilatation Catheter

Primary DI
06958481475210
Brand
Tiche PTA Balloon Dilatation Catheter
Company
BrosMed Medical Co.,Ltd.
Model
rev01
Catalog number
34-060440
Published
2023-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212215000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212215000Tiche PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.2022-07-19LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06958481475210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06958481475210069584814752106958481475210

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421318800
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941466829177Balloon Inflation Devicerev 01BM-BID-II302026-05-13
06942265520807Parafleet SC 035 PTA Balloon Dilatation Catheterrev 02F35-060200-2002025-05-13
06942265502018Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-035300-0902025-05-09
06942265502025Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040015-0902025-05-09
06942265502032Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040020-0902025-05-09
06942265502049Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040025-0902025-05-09
06942265502056Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040030-0902025-05-09
06942265502063Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040040-0902025-05-09
06942265502070Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040060-0902025-05-09
06942265502087Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040080-0902025-05-09
06942265502094Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040100-0902025-05-09
06942265502100Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040120-0902025-05-09
06942265502117Parafleet SC 014PTA Balloon Dilatation Catheterrev 02F14-040150-0902025-05-09
06942265502124Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040200-0902025-05-09
06942265502131Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040220-0902025-05-09
06942265502148Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040250-0902025-05-09
06942265502155F14-040300-090rev 01F14-040300-0902025-05-09
06942265502162Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-045015-0902025-05-09
06942265502179Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-045020-0902025-05-09
06942265502186Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-045025-0902025-05-09

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H965914004000NAMICNAVILYST MEDICAL, INC.LIT2016-09-21
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