FDA.reportPublic FDA data

ETHICON

Primary DI
20705031462530
Brand
ETHICON
Company
ETHICON INC.
Model
VSTAS1
Catalog number
VSTAS1
Device description
VISTASEAL DUAL APPLICATOR
Published
2019-10-01
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
MZMFibrin sealant preparation device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZMFibrin Sealant Preparation Device General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031462530PackageGS115In Commercial Distribution
20705031466934PackageGS13In Commercial Distribution
30705031462537PackageGS1120In Commercial Distribution
30705031466931PackageGS1120In Commercial Distribution
10705031462533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503146253020705031462530
2070503146693420705031466934
3070503146253730705031462537
3070503146693130705031466931
1070503146253310705031462533

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate/haemostatic agent cannula, open-surgeryA flexible or rigid tube intended to be used during an open surgical procedure for the administration of a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, polysaccharide) to a bleeding surgical site, typically to facilitate haemostasis and healing. It may have a single channel, to administer one product, or dual channels for co-administration of two different agents simultaneously; a channel for connection to a gas pump for spraying may also be incorporated. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
002144145
Device count
1
DM exempt
false
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
10705031005235BIOPATCH415041502016-06-20
10705031005242BIOPATCH415141512016-06-20
10705031005259BIOPATCH415241522016-06-20
10705031029309ETHIBOND EXCELD8150D81502015-09-01
10705031030572ETHIBOND EXCELD8572D85722015-09-01
10705031058552ETHIBOND EXCELX997GX997G2015-09-01
10705031088351MERSILENE1765G1765G2020-04-14
10705031204553ETHIBOND EXCELD8573D85732015-09-01
10705031206403ENDOKNOTEX10GEX10G2015-09-25
10705031049703MERSILENER833HR833H2015-09-01
10705031001107BIOPATCH10150101502016-07-18
10705031001114BIOPATCH10151101512016-06-20
10705031001121BIOPATCH10152101522016-06-20
10705031036826ETHICONDW31BDW31B2015-09-01
10705031206427ENDOLOOPEZ10GEZ10G2015-09-24
10705031206458ENDOKNOTJK10GJK10G2015-09-24
10705031206465ENDOLOOPEJ10GEJ10G2015-09-24
10705031206489PDSZK10GZK10G2015-09-24
10705031206885LAPRA-TYXC200XC2002015-09-25
10705031238909ETHICOND10191D101912016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031462533ETHICONEthicon Inc.MZM2019-10-01
10705031462571ETHICONEthicon Inc.MZM2019-10-01
10705031462724ETHICONEthicon Inc.MZM2019-10-01
20705031462578ETHICONETHICON INC.MZM2019-10-01
30705031462728ETHICONETHICON INC.MZM2019-10-01
10705031240469ETHICONEthicon Inc.MZM2018-03-20
20705031240466ETHICONETHICON INC.MZM2018-03-20
10705031230132ETHICONEthicon Inc.MZM2015-09-23
20705031230139ETHICONETHICON INC.MZM2015-09-23