FDA.reportPublic FDA data

MesireTM Sinus Balloon Catheter

Primary DI
18904224901466
Brand
MesireTM Sinus Balloon Catheter
Company
MERIL LIFE SCIENCES PRIVATE LIMITED
Model
MSB50017
Catalog number
MSB50017
Device description
MesireTM Sinus Balloon Catheter, 5.00 mm x 17 mm
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
18904224901466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1890422490146618904224901466

GMDN Terms#

Term, Definition table
TermDefinition
Nasal/paranasal balloon catheterA sterile flexible tube with an inflatable balloon at its distal tip designed to gently restructure nasal passages and dilate obstructed sinus ostia during a surgical procedure (sinuplasty), typically to treat sinusitis, and/or to gently restructure nasal passages to temporarily relieve nasal obstruction/congestion. The device typically consists of a single-lumen tube with a connector at the proximal end for attachment to an inflation device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length17Millimeter
Outer Diameter5Millimeter

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
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
18906029358117MozecTM NC Rx PTCA Balloon Dilatation CatheterMNC22508MNC225082016-08-29

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