ETHICON

Primary DI
30705031462728
Brand
ETHICON
Company
ETHICON INC.
Model
VSTL45
Catalog number
VSTL45
Device description
Laparoscopic Dual Flexible 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1903240

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1903240

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031462721PackageGS13In Commercial Distribution
30705031462728PackageGS172In Commercial Distribution
10705031462724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503146272120705031462721
3070503146272830705031462728
1070503146272410705031462724

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate/haemostatic agent cannula, endoscopic, single-useA long flexible or rigid tube with an atraumatic tip intended to be used during an endoscopic/laparoscopic procedure to provide access 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 is designed to be inserted into the body percutaneously, via a port or rigid endoscope (e.g., laparoscope). 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 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
20705031462530ETHICONETHICON INC.MZM2019-10-01
20705031462578ETHICONETHICON INC.MZM2019-10-01
10705031240469ETHICONEthicon Inc.MZM2018-03-20
20705031240466ETHICONETHICON INC.MZM2018-03-20
10705031230132ETHICONEthicon Inc.MZM2015-09-23
20705031230139ETHICONETHICON INC.MZM2015-09-23