FDA.reportPublic FDA data

MesireTM Guide - Sinus Guide Catheter

Primary DI
18904224901503
Brand
MesireTM Guide - Sinus Guide Catheter
Company
MERIL LIFE SCIENCES PRIVATE LIMITED
Model
MSG030
Catalog number
MSG030
Device description
MesireTM Guide - Sinus Guide Catheter, Angle 30°
Published
2018-05-30
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
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172737000MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited2017-12-12LRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18904224901503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1890422490150318904224901503

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus guide-catheterA sterile cannula-like catheter consisting of a tube with a tip designed to facilitate placement of other devices into or near different sinus ostia. It is used to provide a channel to access the sinus space during diagnostic and therapeutic procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle30degree

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at or below 40°C; temperature

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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