FDA.reportPublic FDA data

QuiCover

Primary DI
06972060310532
Brand
QuiCover
Company
Hangzhou Zeo-Innov Life Technology Co., Ltd.
Model
0.3g
Device description
The Zeolite Hemostatic Cotton consists of zeolite and cotton. It is provided in a sterile dressing format that conforms readily to the wound. There are 15 models of Zeolite Hemostatic Cotton, and the size ranges from 0.1g to 10g. The difference between each model is weight.
Published
2024-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

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
K223495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223495000Zeolite Hemostatic CottonHangzhou Zeo-Innov Life Technology Co., Ltd.2023-05-02QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972060310563PackageGS160In Commercial Distribution
06972060310532PrimaryGS10
06972060310570Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972060310563069720603105636972060310563
06972060310532069720603105326972060310532
06972060310570069720603105706972060310570

GMDN Terms#

Term, Definition table
TermDefinition
Non-organic haemostatic agentA non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight10Gram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
541290694
Device count
8
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972060310457QuiCoverP-9cm×10cm-12,2 pieces/bag2023-09-01
06972060310464QuiCoverP-9cm×10cm-12,2 pieces/bag2023-09-01
06972060310174QuiCoverP09101222022-06-07
06972060310235QuiCoverP09101222022-06-07

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