MesireTM Sinus Balloon Catheter MSB70017

GUDID 18904224901480

MesireTM Sinus Balloon Catheter, 7.00 mm x 17 mm

MERIL LIFE SCIENCES PRIVATE LIMITED

Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter
Primary Device ID18904224901480
NIH Device Record Key381011b9-13da-4f72-857e-1baea6f31291
Commercial Distribution StatusIn Commercial Distribution
Brand NameMesireTM Sinus Balloon Catheter
Version Model NumberMSB70017
Catalog NumberMSB70017
Company DUNS650328680
Company NameMERIL LIFE SCIENCES PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (609) 951 2287
Emailaskmozec@merillife.com
Phone+1 (609) 951 2287
Emailaskmozec@merillife.com

Device Dimensions

Outer Diameter7 Millimeter
Outer Diameter7 Millimeter
Outer Diameter7 Millimeter
Outer Diameter7 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at or below 40°C; temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at or below 40°C; temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS118904224901480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRCInstrument, Ent Manual Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2018-05-30

On-Brand Devices [MesireTM Sinus Balloon Catheter]

18904224901480MesireTM Sinus Balloon Catheter, 7.00 mm x 17 mm
18904224901473MesireTM Sinus Balloon Catheter, 6.00 mm x 17 mm

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