FDA.reportPublic FDA data

NexStat Plus 3gm

Primary DI
00858439001408
Brand
NexStat Plus 3gm
Company
HEMOSTASIS, LLC
Model
9430034
Device description
The hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. The hemostatic particles quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
Published
2020-09-30
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
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122886000NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSINGHemostasis, LLC2012-11-15QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858439001408PackageGS15In Commercial Distribution
00858439001323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858439001408008584390014088584390014080858439001408
00858439001323008584390013238584390013230858439001323

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobialA non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight3Gram

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
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

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