AccessGUDID - DEVICE: Invotec Nasal Septal Button (00818501020010)

GUDID

Device Identifier (DI) Information

Brand Name: Invotec Nasal Septal Button
Version or Model: 001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-10400S
Company Name: INVOTEC INTERNATIONAL, INC.

Primary DI Number: 00818501020010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622812592 *Terms of Use

Device Description: A device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration.

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?
46397	Nasal septal button	A device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LFB	Button, Nasal Septal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K901366	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 053f02f1-7cce-4002-a30a-2706e911b198
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 03, 2017