FDA.reportPublic FDA data

Tridyne™ Vascular Sealant

Primary DI
10801741099363
Brand
Tridyne™ Vascular Sealant
Company
NEOMEND, INC.
Model
TDVS004
Catalog number
TDVS004
Device description
Tridyne Vascular Sealant
Published
2018-10-31
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
NBESealant,polymerizing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBESealant, PolymerizingUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150016000TRIDYNE VASCULAR SEALANTNeomend, Inc.2016-04-11NBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741099363PackageGS14In Commercial Distribution
00801741099366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174109936310801741099363
00801741099366008017410993668017410993660801741099366

GMDN Terms#

Term, Definition table
TermDefinition
Surgical adhesive/sealant, human-derivedA sterile, bioabsorbable substance containing human-derived material [e.g., human serum albumin (HSA)] intended to be used for internal surgical applications to bond or seal cut, incised, or resected body tissues typically as an adjunct to standard methods of closure, seal leaks, and/or to achieve haemostasis. Disposable mixing devices/applicators may be included for preparation and application to anatomical sites. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume4Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)776-4351medical.services@crbard.com
+1(888)776-4351medical.services@bd.com

Regulatory Flags#

DUNS number
195251595
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
true
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
00801741010026ProgelPGPS002PGPS0022014-09-12
00801741099366TridyneTDVS004TDVS0042018-10-31
10801741010030ProgelPGST009PGST0092014-09-12
10801741099370TridyneTDST0020TDST00202018-10-31
00801741010002ProgelPGEN005-06PGEN005-062014-09-12
00801741010019ProgelPGEN005-11PGEN005-112014-09-12
00801741099380TridyneTDET0006TDET00062018-10-31
20801741010037Progel™ Applicator Spray TipsPGST009PGST0092014-09-12
20801741099377Tridyne™ Vascular Sealant Standard Spray TipsTDST0020TDST00202018-10-31
10801741010009Progel™Extended Applicator Spray TipPGEN005-06PGEN005-062014-09-12
10801741010016Progel™Extended Applicator Spray TipPGEN005-11PGEN005-112014-09-12
10801741099387Tridyne™ Vascular Sealant Extended Spray TipsTDET0006TDET00062018-10-31
10801741010023Progel™ Pleural Air Leak SealantPGPS002PGPS0022014-09-12

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
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
30705031133109ETHICON 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