FDA.reportPublic FDA data

PosiSep X2 0.8" x 2.3"

Primary DI
00858439001910
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYASplint, Intranasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120958000POSISEP AND POSISEP X HEMOSTAT DRESSINGSHemostasis, LLC2012-07-25QSY

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, professionalA 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

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
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00858439001248PosiSep 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint92105542020-02-20
00858439001972NexStat 1gm91301542021-05-03
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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Primary DI, Brand, Company table
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