FDA.reportPublic FDA data

ETHICON OMNEX

Primary DI
30705031133109
Brand
ETHICON OMNEX
Company
ETHICON INC.
Model
4901
Catalog number
4901
Published
2014-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NBESealant,polymerizing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBESealant, PolymerizingUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031133102PackageGS14Not in Commercial Distribution
30705031133109PackageGS14Not in Commercial Distribution
10705031133105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503113310220705031133102
3070503113310930705031133109
1070503113310510705031133105

GMDN Terms#

Term, Definition table
TermDefinition
Skin-approximation adhesiveA sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Resterilize
Storage Environment Temperature025 Degrees Celsius
Storage Environment Temperature077 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

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
05413765583520PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
05413765583582PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
25413765583524PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
25413765583586PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2022-02-22
05413765583599PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
05413765583605PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
25413765583593PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
25413765583609PREVELEAK SURGICAL SEALANTBaxter Healthcare CorporationNBE2021-06-01
05413765583414COSEAL SPRAY SETBAXTER HEALTHCARE CORPORATIONNBE2020-09-30
35413765583415COSEAL SPRAY SETBAXTER HEALTHCARE CORPORATIONNBE2020-09-30
10801741099370TridyneNEOMEND, INC.NBE2018-10-31
00801741099366TridyneNEOMEND, INC.NBE2018-10-31
00801741099380TridyneNEOMEND, INC.NBE2018-10-31
20801741099377Tridyne™ Vascular Sealant Standard Spray TipsNEOMEND, INC.NBE2018-10-31
10801741099363Tridyne™ Vascular SealantNEOMEND, INC.NBE2018-10-31
10801741099387Tridyne™ Vascular Sealant Extended Spray TipsNEOMEND, INC.NBE2018-10-31
00085412083322Coseal Surgical Sealant Replacement ApplicatorBAXTER HEALTHCARE CORPORATIONNBE2017-10-09
50085412083327Coseal Surgical Sealant Replacement ApplicatorBAXTER HEALTHCARE CORPORATIONNBE2017-10-09
00085412083339Coseal Surgical Sealant Extended ApplicatorBAXTER HEALTHCARE CORPORATIONNBE2017-10-09
00085412087788Coseal Spray SetBaxter Healthcare SANBE2017-03-23
00850868002049PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2015-12-31
00850868002056PreveLeak™ 10 pack TipsTenaxis Medical, Inc.NBE2015-12-31
05413765404627Coseal Surgical SealantBAXTER HEALTHCARE CORPORATIONNBE2015-06-10
05413765404634Coseal Surgical SealantBAXTER HEALTHCARE CORPORATIONNBE2015-05-05
05413765404610Coseal Surgical SealantBAXTER HEALTHCARE CORPORATIONNBE2015-05-04
10705031133105ETHICON OMNEXEthicon Inc.NBE2014-09-20
00850868002025PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2014-09-15
00850868002032PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2014-09-15
00850868002063PreveLeak™ Surgical SealantTenaxis Medical, Inc.NBE2014-09-15
10801741010030ProgelNEOMEND, INC.NBE2014-09-12