FDA.reportPublic FDA data

ETHICON

Primary DI
20705031240466
Brand
ETHICON
Company
ETHICON INC.
Model
3922S
Catalog number
3922S
Device description
Evicel Laparoscopic Airless Spray Accessory
Published
2018-03-20
Public version status
Update
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
BK1701380

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1701380

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031240466PackageGS13In Commercial Distribution
30705031240463PackageGS172In Commercial Distribution
10705031240469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503124046620705031240466
3070503124046330705031240463
1070503124046910705031240469

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate applicatorA hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate (e.g., thrombin, collagen, platelet concentrate, bone marrow aspirate concentrate) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged

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
true
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
30705031462728ETHICONETHICON INC.MZM2019-10-01
10705031240469ETHICONEthicon Inc.MZM2018-03-20
10705031230132ETHICONEthicon Inc.MZM2015-09-23
20705031230139ETHICONETHICON INC.MZM2015-09-23