AccessGUDID - DEVICE: OSSEOUS (08904428722501)

GUDID

Device Identifier (DI) Information

Brand Name: OSSEOUS
Version or Model: E7185-SC
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EON MEDITECH PRIVATE LIMITED

Primary DI Number: 08904428722501
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 930270428 *Terms of Use

Device Description: Standard Nasal Dressings sponges are designed to be placed inside the nasal cavities for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and allowing smooth septum ventilation to ensure patient comfort. The device in invasive with respect to body orifice.

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):	Yes
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?
47679	Nasal mucosa dressing, non-antimicrobial	A material (e.g., solution, spray, gel, oil, balm) intended to be applied to nasal mucosa for one or a variety of therapeutic applications such as providing a protective barrier, hydrating the mucosa, washing/removing excessive secretions, loosening nasal encrustations, and/or reducing mucosal irritation/inflammation/oedema from environmental exposures (e.g., pet allergens, pollen), infection, or postsurgical healing, or for snoring control. It is composed of one or a combination of compounds (e.g., acids, provitamins, mannitol); it does not include an antimicrobial agent(s). It is intended for use in the home or a clinical setting. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMX	Balloon, Epistaxis

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
Length: 10 Centimeter
Height: 1.5 Centimeter
Width: 2.5 Centimeter

Device Record Status

Public Device Record Key: 0aa9eb1e-ae43-463c-a940-0b208a698234
Public Version Date: June 19, 2024
Public Version Number: 1
DI Record Publish Date: June 11, 2024