AccessGUDID - DEVICE: PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint (00858439001330)

GUDID

Device Identifier (DI) Information

Brand Name: PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint
Version or Model: 9210584
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEMOSTASIS, LLC

Primary DI Number: 00858439001330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801380697 *Terms of Use

Device Description: PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.

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?
46922	Chitosan haemostatic agent, professional, non-bioabsorbable	A non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied exclusively by healthcare professionals in a clinical setting to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.	Active	false
64402	Intranasal splint, non-bioabsorbable, animal-derived	A non-bioabsorbable 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 made from animal-derived materials (e.g., chitosan) 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
LYA	Splint, Intranasal Septal
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120958	000
K122494	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: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Width: 1.5 Centimeter
Length: 5.1 Centimeter

Device Record Status

Public Device Record Key: 595d2ad2-d60f-4ad6-b7c3-738ed27d235c
Public Version Date: January 20, 2025
Public Version Number: 4
DI Record Publish Date: February 20, 2020