AccessGUDID - DEVICE: Mueller Nasal Sponges (00074676191218)

GUDID

Device Identifier (DI) Information

Brand Name: Mueller Nasal Sponges
Version or Model: 191201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 191201
Company Name: Mueller Sports Medicine, Inc.

Primary DI Number: 00074676191218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 006426316 *Terms of Use

Device Description: NASAL SPONGES, 25 PACK

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):	Yes
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?
65150	Nasal haemostatic plug	A small piece of material intended to be inserted into the nose to apply pressure within the nasal cavity to control nose bleeding (epistaxis) and provide a barrier in the nostril to prevent blood drip. It is made of either an expandable foam material which may provide some degree of blood absorption, or fatty plant-derived materials which melt over time lubricating the nostril to prevent further damage when the device is removed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYA	SPLINT, INTRANASAL SEPTAL

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
Length: 1.5 Inch
Width: 7 Inch

Device Record Status

Public Device Record Key: 2c1dcb4c-22bd-4d76-862c-ffd9d27fd8f6
Public Version Date: May 03, 2023
Public Version Number: 2
DI Record Publish Date: August 31, 2022