AccessGUDID - DEVICE: OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades

GUDID

Device Identifier (DI) Information

Brand Name: OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - M Type
Version or Model: EI2204
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EON MEDITECH PRIVATE LIMITED

Primary DI Number: 08904461000529
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 930270428 *Terms of Use

Device Description: ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system to remove tissue, bone, or other obstructions in the sinuses.

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?
47523	Nasal biopsy curette	A sterile, hand-held, manual instrument designed to remove nasal mucosal cells, intended for laboratory examination and/or testing, usually by gently scraping the inferior surface of the inferior turbinate. The instrument typically has a spoon-like working end and a flexible handle; it is typically made of plastic. It is commonly used to collect samples for testing to determine the respiratory epithelial response to air pollutants and for assessing drug effects [e.g., in cystic fibrosis (CF) patients]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EQJ	Bur, Ear, Nose And Throat

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 Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4.0 Millimeter
Angle: 40 degree

Device Record Status

Public Device Record Key: f4765641-782d-4a09-a25e-58fbc6c0b6fa
Public Version Date: July 18, 2024
Public Version Number: 1
DI Record Publish Date: July 10, 2024