AccessGUDID - DEVICE: RHINOCELL® Nasal Packing (EBESTP8010300)

GUDID

Device Identifier (DI) Information

Brand Name: RHINOCELL® Nasal Packing
Version or Model: TP-801030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TP-801030
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBESTP8010300
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 8.0 x 1.0 x 3.0 cm; Type: Anatomical ThinPack

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: 8.0 Centimeter
Height: 1.0 Centimeter
Width: 3.0 Centimeter

Device Record Status

Public Device Record Key: d1dd8556-95b6-4ef3-97b5-2e9eefd13864
Public Version Date: August 30, 2022
Public Version Number: 6
DI Record Publish Date: September 20, 2015