AccessGUDID - DEVICE: OSSEOUS Silicone Sheets (08906039310573)

GUDID

Device Identifier (DI) Information

Brand Name: OSSEOUS Silicone Sheets
Version or Model: E3146UUS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EON MEDITECH PRIVATE LIMITED

Primary DI Number: 08906039310573
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?
61557	Silicone-sheet tissue reconstructive material	A flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different sizes and shapes for various reconstructive surgery applications (e.g., repair of nasal septum or orbital floor, perforated eardrum, or hernia/fissure of abdominal wall).	Active	true

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
Height: 0.13 Millimeter

Device Record Status

Public Device Record Key: ea522b83-3a59-47a4-8ccc-7249d786685e
Public Version Date: July 11, 2024
Public Version Number: 1
DI Record Publish Date: July 03, 2024