AccessGUDID - DEVICE: OSSEOUS Aluminium Splint Kit (08906039316490)

GUDID

Device Identifier (DI) Information

Brand Name: OSSEOUS Aluminium Splint Kit
Version or Model: E6149K
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EON MEDITECH PRIVATE LIMITED

Primary DI Number: 08906039316490
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 930270428 *Terms of Use

Device Description: External Aluminium Nasal Splint splinting of nasal dorsum after Rhinoplastly and 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:	Yes
Combination Product:	Yes
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?
35411	External nasal splint	A rigid or semi-rigid device intended to be applied externally to the nose for the immobilization of nasal bones and cartilage, typically after a fracture or surgery. It functions as a truss-like support on the outside of the nose. 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: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 99c97301-9c51-4c6a-a2d0-d9a1692d1086
Public Version Date: July 12, 2024
Public Version Number: 1
DI Record Publish Date: July 04, 2024