FDA.reportPublic FDA data

Hemospray

Primary DI
00827002210493
Brand
Hemospray
Company
COOK INCORPORATED
Model
G21049
Catalog number
HEMO-10
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
00827002210493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002210493008270022104938270022104930827002210493

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
00827002606616OpTUS Ultra PleuralG60661OPTUS-SET-5.5-15-PIGTAIL2026-10-22
00827002606623OpTUS Ultra PleuralG60662OPTUS-TRAY-5.5-15-PIGTAIL2026-10-22
00827002606630OpTUS Ultra PleuralG60663OPTUS-SET-8.5-20-PIGTAIL2026-10-22
00827002606647OpTUS Ultra PleuralG60664OPTUS-TRAY-8.5-20-PIGTAIL2026-10-22
00827002606654OpTUS Ultra PleuralG60665OPTUS-SET-10-20-PIGTAIL2026-10-22
00827002606661OpTUS Ultra PleuralG60666OPTUS-TRAY-10-20-PIGTAIL2026-10-22
00827002606678OpTUS Ultra PleuralG60667OPTUS-SET-12-30-STRAIGHT2026-10-22
00827002606685OpTUS Ultra PleuralG60668OPTUS-TRAY-12-30-STRAIGHT2026-10-22
00827002606692OpTUS Ultra PleuralG60669OPTUS-SET-12-30-PIGTAIL2026-10-22
00827002606708OpTUS Ultra PleuralG60670OPTUS-TRAY-12-30-PIGTAIL2026-10-22
00827002606715OpTUS Ultra PleuralG60671OPTUS-SET-14-30-STRAIGHT2026-10-22
00827002606722OpTUS Ultra PleuralG60672OPTUS-TRAY-14-30-STRAIGHT2026-10-22
00827002606739OpTUS Ultra PleuralG60673OPTUS-SET-14-30-PIGTAIL2026-10-22
00827002606746OpTUS Ultra PleuralG60674OPTUS-TRAY-14-30-PIGTAIL2026-10-22
00827002606753OpTUS Ultra PleuralG60675OPTUS-SET-16-30-STRAIGHT2026-10-22
00827002606760OpTUS Ultra PleuralG60676OPTUS-TRAY-16-30-STRAIGHT2026-10-22
00827002606777OpTUS Ultra PleuralG60677OPTUS-SET-16-30-PIGTAIL2026-10-22
00827002606784OpTUS Ultra PleuralG60678OPTUS-TRAY-16-30-PIGTAIL2026-10-22
00827002606791OpTUS Ultra PleuralG60679OPTUS-SET-20-30-STRAIGHT2026-10-22
00827002606807OpTUS Ultra PleuralG60680OPTUS-TRAY-20-30-STRAIGHT2026-10-22

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
00827002565722HemosprayCOOK INCORPORATEDQAU2018-05-25