FDA.reportPublic FDA data

"PosiSep X2 0.8"" x 2.3"""

Primary DI
00858439001903
Brand
"PosiSep X2 0.8"" x 2.3"""
Company
HEMOSTASIS, LLC
Model
9210615
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.
Published
2021-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMXBalloon, Epistaxis
FRODressing, Wound, Drug
LYASplint, Intranasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1
FRODressing, Wound, DrugUnknownU
LYASplint, Intranasal SeptalEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120958000
K122494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120958000POSISEP AND POSISEP X HEMOSTAT DRESSINGSHemostasis, LLC2012-07-25QSY
K122494000POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINTHemostasis, LLC2013-03-27LYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858439001910PackageGS15In Commercial Distribution
00858439001903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858439001910008584390019108584390019100858439001910
00858439001903008584390019038584390019030858439001903

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agent, professional, non-bioabsorbableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.3Inch
Width0.8Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature

Contacts#

Phone, Email table
PhoneEmail
+1 651-855-1466customerservice@hemostasisllc.com

Regulatory Flags#

DUNS number
801380697
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858439001552BoneSeal 2x2.5 gram Ingot95500742019-05-06
00858439001699ExcelArrest XT 2x2 Hemostatic Patch92102232020-11-20
00858439001774AeroClear97700132020-11-30
00858439001279PosiSep X 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint92105642020-02-20
00858439001309PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint92105742020-02-20
00858439001330PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint92105842020-02-20
00858439001361PosiSep X 8.0 cm x 1.8 cm Hemostatic Dressing/Intranasal Splint92106042020-02-20
00858439001385PosiSep C92107542020-02-20
00858439001415PosiSep C²92107642020-02-20
00858439001675PosiSep C 0.6 x 2.092108542020-09-30
00858439001880"PosiSep X2 0.7"" x 1.7"""92106142021-05-03
00858439001248PosiSep 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint92105542020-02-20
00858439001972NexStat 1gm91301542021-05-03
00858439001910PosiSep X2 0.8" x 2.3"92106152021-05-03
00858439001989NexStat 1gm91301542021-05-03
00858439001613NexPak91105242020-09-30
00858439001637NexPak X91105342020-09-30
00858439001705ExcelArrest XT 2x2 Hemostatic Patch92102232020-11-20
00858439001262NexStat Plus 2gm94300142020-09-30
00858439001323NexStat Plus 3gm94300342020-09-30

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