AccessGUDID - DEVICE: RHINOCELL® Epistaxis Packing (EBESEP10015250)

GUDID

Device Identifier (DI) Information

Brand Name: RHINOCELL® Epistaxis Packing
Version or Model: EP-1001525
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EP-1001525
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBESEP10015250
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 10.0 x 1.5 x 2.5 cm

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?
31919	Intranasal splint, non-biodegradable	A non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMX	Balloon, Epistaxis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972459	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
Length: 10.0 Centimeter
Height: 1.5 Centimeter
Width: 2.5 Centimeter

Device Record Status

Public Device Record Key: 75ad5cfa-b515-4dfc-9b21-73b0ab97b793
Public Version Date: August 30, 2022
Public Version Number: 6
DI Record Publish Date: September 20, 2015