FDA.reportPublic FDA data

ETHICON

Primary DI
20705031230139
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
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
FMFSyringe, piston
MZMFibrin sealant preparation device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
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
20705031230139PackageGS110In Commercial Distribution
30705031230136PackageGS110In 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 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
Storage Environment Temperature030 Degrees Celsius
Storage Environment Temperature086 Degrees Fahrenheit

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
10705031462571VISTASEALVSTL35VSTL352019-10-01
10705031462724VISTASEALVSTL45VSTL452019-10-01
10705031462533VISTASEALVSTAS1VSTAS1, VSTAS1E2019-10-01
10705031131958ETHICONMS1995MS19952015-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530754033Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754057Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754118Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754149polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754170polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754255polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754279polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754286polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754323polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754385polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754415polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754477polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754484polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754651polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754736polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
M992MTINS0331081MedThermalCarelife (usa) Inc.FMF2026-09-18
00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070372CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070389CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070396CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070402CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070419CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
06976523540238Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14