PosiSep X2 0.8" x 2.3"

Basic Information

• Brand Name: PosiSep X2 0.8" x 2.3"
• Primary DI: 00858439001903
• Version / Model: 9210615
• Company Name: HEMOSTASIS, LLC
• Labeler DUNS: 801380697
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-03
• Public Version: 1
• Public Version Date: 2021-05-11
• Public Version Status: New
• Public Device Record Key: 4eb84958-c1de-4015-a21a-67c507526302

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	874.4780	1
EMX	Balloon, Epistaxis	Ear, Nose, Throat	874.4100	1
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46922	Chitosan haemostatic agent, professional	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00858439001910	GS1	Carton	5	In Commercial Distribution
Primary	00858439001903	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K120958	000
K122494	000

Device Sizes

Type	Value	Unit	Text
Width	0.8	Inch
Length	2.3	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature