AccessGUDID - DEVICE: MesireTM Guide - Sinus Guide Catheter (18904224901497)

GUDID

Device Identifier (DI) Information

Brand Name: MesireTM Guide - Sinus Guide Catheter
Version or Model: MSG000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MSG000
Company Name: MERIL LIFE SCIENCES PRIVATE LIMITED

Primary DI Number: 18904224901497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 650328680 *Terms of Use

Device Description: MesireTM Guide - Sinus Guide Catheter, Angle 0°

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48142	Paranasal sinus guide-catheter	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	Instrument, Ent Manual Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172737	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at or below 40°C; temperature

Clinically Relevant Size

[?]

Size Type Text
Angle: 0 degree

Device Record Status

Public Device Record Key: 2b83c500-ec3c-41c5-a740-cde68c1287fa
Public Version Date: October 05, 2018
Public Version Number: 3
DI Record Publish Date: May 30, 2018