ETHICON

Primary DI
10705031230132
Brand
ETHICON
Company
Ethicon Inc.
Model
3921S
Catalog number
3921S
Device description
Evicel Airless Spray Accessory
Published
2015-09-23
Public version status
Update
Distribution status
Not 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
MZMFibrin sealant preparation device

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1400930

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1400930

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031230139PackageGS110Not in Commercial Distribution
30705031230136PackageGS110Not in Commercial Distribution
10705031230132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503123013920705031230139
3070503123013630705031230136
1070503123013210705031230132

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate/haemostatic agent applicator 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, in conjunction with an applicator such as a syringe/plunger [not included]. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature030 Degrees Celsius
Storage Environment Temperature086 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
002144145
Device count
1
Lot or batch
true
Expiration date on label
true

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
30705031462728ETHICONETHICON INC.MZM2019-10-01
10705031240469ETHICONEthicon Inc.MZM2018-03-20
20705031240466ETHICONETHICON INC.MZM2018-03-20
20705031230139ETHICONETHICON INC.MZM2015-09-23