Hemospray

Primary DI
00827002565722
Brand
Hemospray
Company
COOK INCORPORATED
Model
G56572
Catalog number
HEMO-7
Device description
HEMOSPRAY ENDOSCOPIC HEMOSTAT
Published
2018-05-25
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
QAUHemostatic device for endoscopic gastrointestinal use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAUHemostatic Device For Endoscopic Gastrointestinal UseGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170015000Hemospray Endoscopic HemostatWilson-Cook Medical, Inc.2018-05-07QAU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002565722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002565722008270025657228270025657220827002565722

GMDN Terms#

Term, Definition table
TermDefinition
Inorganic haemostatic agent, sterileA sterile, 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 may also 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 devices to assist application may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
079720472
Device count
1
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
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800038405325NexpowderNEXTBIOMEDICAL CO., LTD.QAU2023-10-05
08800038405332NexpowderNEXTBIOMEDICAL CO., LTD.QAU2023-10-05
00860001820867PuraStat (1mL)3-D MATRIX INC.QAU2023-08-28
00860001820874PuraStat (3mL)3-D MATRIX INC.QAU2023-08-28
08800038405189NexpowderNEXTBIOMEDICAL CO., LTD.QAU2022-09-27
18800038405186NexpowderNEXTBIOMEDICAL CO., LTD.QAU2022-09-27
16972011720011EndoClotEndoClot Plus Co.,Ltd.QAU2022-03-15
26972011720018EndoClotEndoClot Plus Co.,Ltd.QAU2022-03-15
00827002210493HemosprayCOOK INCORPORATEDQAU2018-05-25