AccessGUDID - DEVICE: Nasal Septal Button (EBES601010)

GUDID

Device Identifier (DI) Information

Brand Name: Nasal Septal Button
Version or Model: 60-101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-101
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBES601010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 3.2 cm; Type: Clear

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
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 [?]
K972060	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
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 32 Millimeter

Device Record Status

Public Device Record Key: 368e3c15-96d6-415c-84d6-439ca826950b
Public Version Date: August 30, 2022
Public Version Number: 4
DI Record Publish Date: September 20, 2015