AccessGUDID - DEVICE: PuraSinus 5mL (00860001820829)

GUDID

Device Identifier (DI) Information

Brand Name: PuraSinus 5mL
Version or Model: 651-009
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 3-D MATRIX INC.

Primary DI Number: 00860001820829
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058207695 *Terms of Use

Device Description: PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL)

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):	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?
41493	Intranasal splint, biodegradable	A bioabsorbable device intended to be 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 made of non-animal source material which chemically degrades after about 3 – 4 weeks and is absorbed via natural body processes, or it may be removed at the discretion of the physician. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183015	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd7c5e5e-b04c-4b37-87ca-ebbb9bd92bb2
Public Version Date: July 21, 2022
Public Version Number: 1
DI Record Publish Date: July 13, 2022