FDA.reportPublic FDA data

MozecTM Rx PTCA Balloon Dilatation Catheter

Primary DI
18904224908205
Brand
MozecTM Rx PTCA Balloon Dilatation Catheter
Company
MERIL LIFE SCIENCES PRIVATE LIMITED
Model
MOZ45033
Catalog number
MOZ45033
Device description
MozecTM Rx PTCA Balloon Dilatation Catheter, 4.50 mm x 33 mm, Rapid Exchange
Published
2016-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131169000MOZEC - RX PTCA BALLOON DILATATION CATHETERMeril Life Sciences Private Limited2013-12-24LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18904224908205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1890422490820518904224908205

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33Millimeter
Outer Diameter4.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry and dark place, in its original packaging

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (609) 951 2287askmozec@merillife.com

Regulatory Flags#

DUNS number
650328680
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18904224901466MesireTM Sinus Balloon Catheter MSB50017MSB500172018-05-30
18904224901473MesireTM Sinus Balloon CatheterMSB60017MSB600172018-05-30
18904224901480MesireTM Sinus Balloon CatheterMSB70017MSB700172018-05-30
18904224905709MesireTM Latch - Catheter Holding System MSLMSL2018-05-30
18904224907710MozecTM Rx PTCA Balloon Dilatation CatheterMOZ25017MOZ250172016-08-03
18904224907727MozecTM Rx PTCA Balloon Dilatation CatheterMOZ25020MOZ250202016-08-03
18904224907741MozecTM Rx PTCA Balloon Dilatation CatheterMOZ25030MOZ250302016-08-03
18904224907765MozecTM Rx PTCA Balloon Dilatation CatheterMOZ25038MOZ250382016-10-10
18904224907789MozecTM Rx PTCA Balloon Dilatation CatheterMOZ27509MOZ275092016-08-03
18904224907796MozecTM Rx PTCA Balloon Dilatation CatheterMOZ27514MOZ275142016-08-03
18904224907802MozecTM Rx PTCA Balloon Dilatation CatheterMOZ27517MOZ275172016-08-03
18904224907819MozecTM Rx PTCA Balloon Dilatation CatheterMOZ27520MOZ275202016-08-03
18904224907826MozecTM Rx PTCA Balloon Dilatation CatheterMOZ27525MOZ275252016-08-03
18904224907833MozecTM Rx PTCA Balloon Dilatation CatheterMOZ27530MOZ275302016-08-03
18904224907840MozecTM Rx PTCA Balloon Dilatation CatheterMOZ27533MOZ275332016-08-03
18906029358063MozecTM NC Rx PTCA Balloon Dilatation CatheterMNC20015MNC200152016-08-29
18906029358070MozecTM NC Rx PTCA Balloon Dilatation CatheterMNC20018MNC200182016-08-29
18906029358087MozecTM NC Rx PTCA Balloon Dilatation CatheterMNC20023MNC200232016-08-29
18906029358094MozecTM NC Rx PTCA Balloon Dilatation CatheterMNC20028MNC200282016-08-29
18906029358100MozecTM NC Rx PTCA Balloon Dilatation CatheterMNC20030MNC200302016-08-29

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Primary DI, Brand, Company table
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