PosiSep C 0.6 x 2.0

GUDID 00858439001682

PosiSep C 0.6 x 2.0 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C 0.6 x 2.0 devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.

HEMOSTASIS, LLC

Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent Chitosan haemostatic agent, professional Chitosan haemostatic agent, professional Chitosan haemostatic agent, professional Chitosan haemostatic agent, professional Chitosan haemostatic agent, professional Chitosan haemostatic agent, professional Chitosan haemostatic agent, professional Chitosan haemostatic agent, professional Chitosan haemostatic agent, professional
Primary Device ID00858439001682
NIH Device Record Key9cc3770b-a16d-463c-9ad4-eaa70f4e5e8a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePosiSep C 0.6 x 2.0
Version Model Number9210854
Company DUNS801380697
Company NameHEMOSTASIS, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com
Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com

Device Dimensions

Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch
Width0.64 Inch
Length2 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100858439001675 [Primary]
GS100858439001682 [Package]
Contains: 00858439001675
Package: Carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYASplint, Intranasal Septal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-08
Device Publish Date2020-09-30

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 1gm2021-05-11 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th
00858439001774 - AeroClear2020-12-08 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 Patch2020-11-30 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 2gm2020-10-08 The Hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide
00858439001408 - NexStat Plus 3gm2020-10-08 The hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide
00858439001439 - NexStat2020-10-08 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.