AccessGUDID - DEVICE: OSSEOUS Suction tubes for Sinus (08904428724062)

GUDID

Device Identifier (DI) Information

Brand Name: OSSEOUS Suction tubes for Sinus
Version or Model: EI1825100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EON MEDITECH PRIVATE LIMITED

Primary DI Number: 08904428724062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 930270428 *Terms of Use

Device Description: Suction tubes for Sinus are used to remove excess amount of foreign body material from sinus.

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":	Yes
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?
45003	ENT suction dissector	A hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAM	Cannula, Sinus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Humidity: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.5 Millimeter
Length: 100.0 Millimeter
Angle: 30 degree

Device Record Status

Public Device Record Key: e31b3c4f-79a0-43da-9570-6ca028a91ac0
Public Version Date: July 03, 2024
Public Version Number: 1
DI Record Publish Date: June 25, 2024