AccessGUDID - DEVICE: PosiSep X2 0.8" x 2.3" (00858439001903)

GUDID

Device Identifier (DI) Information

Brand Name: PosiSep X2 0.8" x 2.3"
Version or Model: 9210615
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEMOSTASIS, LLC

Primary DI Number: 00858439001903
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801380697 *Terms of Use

Device Description: PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 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

FDA Product Code

[?]

Product Code	Product Code Name
LYA	Splint, Intranasal Septal
EMX	Balloon, Epistaxis
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: 0.8 Inch
Length: 2.3 Inch

Device Record Status

Public Device Record Key: 4eb84958-c1de-4015-a21a-67c507526302
Public Version Date: January 20, 2025
Public Version Number: 2
DI Record Publish Date: May 03, 2021