AccessGUDID - DEVICE: OSSEOUS Internal Nasal Bi-valve Splint

GUDID

Device Identifier (DI) Information

Brand Name: OSSEOUS Internal Nasal Bi-valve Splint - Standard(Silicone)
Version or Model: E3148SS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EON MEDITECH PRIVATE LIMITED

Primary DI Number: 08906039310481
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 930270428 *Terms of Use

Device Description: "Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "

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?
31919	Intranasal splint, non-biodegradable	A non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EPP	Splint, Nasal

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: between 0 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 60.00 Millimeter
Width: 38.00 Millimeter
Height: 0.50 Millimeter

Device Record Status

Public Device Record Key: c18e0b1f-4059-4215-aeac-de074976afb1
Public Version Date: July 11, 2024
Public Version Number: 1
DI Record Publish Date: July 03, 2024