PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint

GUDID 00858439001316

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

HEMOSTASIS, LLC

Chitosan haemostatic agent

• Primary Device ID: 00858439001316
• NIH Device Record Key: 3e85bf04-3875-4bf7-9859-97581e78f835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint
• Version Model Number: 9210574
• Company DUNS: 801380697
• Company Name: HEMOSTASIS, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com

Device Dimensions

• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter
• Width: 1.5 Centimeter
• Length: 5.1 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858439001309 [Primary]
GS1	00858439001316 [Package]; Contains: 00858439001309; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120958

FDA Product Code

• EMX: Balloon, Epistaxis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-28
• Device Publish Date: 2020-02-20

Devices Manufactured by HEMOSTASIS, LLC

• 00858439001880 - PosiSep X2 0.7" x 1.7": 2021-05-11 PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices e
• 00858439001910 - PosiSep X2 0.8" x 2.3": 2021-05-11 PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices e
• 00858439001989 - NexStat 1gm: 2021-05-11 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th
• 00858439001774 - AeroClear: 2020-12-08 The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. I
• 00858439001705 - ExcelArrest XT 2x2 Hemostatic Patch: 2020-11-30 ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in ste
• 00858439001293 - NexStat Plus 2gm: 2020-10-08 The Hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide
• 00858439001408 - NexStat Plus 3gm: 2020-10-08 The hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide
• 00858439001439 - NexStat: 2020-10-08 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th