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
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03664883000044PuraStat3-D MATRIX EUROPEQAU2026-02-01
04560436590354PuraStat3-D MATRIX EUROPEQAU2025-03-03
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