FDA.reportPublic FDA data

PosiSep 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint

Primary DI
00858439001248
Brand
PosiSep 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint
Company
HEMOSTASIS, LLC
Model
9210554
Device description
PosiSep devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep devices expand when hydrated providing separation between the sinus tissues.
Published
2020-02-20
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
00858439001255PackageGS15In Commercial Distribution
00858439001248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858439001255008584390012558584390012550858439001255
00858439001248008584390012488584390012480858439001248

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-bioabsorbable, animal-derivedA sterile, non-bioabsorbable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and provide support to the surrounding tissues during the healing period. It is made from animal-derived materials (e.g., chitosan) and is removed at the discretion of the physician. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.8Centimeter
Width1.3Centimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
00858439001903"PosiSep X2 0.8"" x 2.3"""92106152021-05-03
00858439001880"PosiSep X2 0.7"" x 1.7"""92106142021-05-03
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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