AccessGUDID - DEVICE: Soft-Form™ Thermo Plastic External Nasal Splint (00818501022465)

GUDID

Device Identifier (DI) Information

Brand Name: Soft-Form™ Thermo Plastic External Nasal Splint
Version or Model: 20-10130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-10130
Company Name: INVOTEC INTERNATIONAL, INC.

Primary DI Number: 00818501022465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622812592 *Terms of Use

Device Description: Soft-Form™ Thermo Plastic External Nasal Splint, Large

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 45d8d949-3652-4900-9ab7-b45e05cd9a88
Public Version Date: December 14, 2022
Public Version Number: 1
DI Record Publish Date: December 06, 2022