FDA.reportPublic FDA data

PreveLeak™ 10 pack Tips

Primary DI
00850868002056
Brand
PreveLeak™ 10 pack Tips
Company
Tenaxis Medical, Inc.
Model
10 pack Tips
Catalog number
8003
Device description
Accessory tips for PreveLeak™ Surgical Sealant
Published
2015-12-31
Public version status
Update
Distribution status
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
NBESealant,Polymerizing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBESealant, PolymerizingUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850868002056PrimaryGS10
00850868002070Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850868002056008508680020568508680020560850868002056
00850868002070008508680020708508680020700850868002070

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-691-9016xxx@xxx.xxx

Regulatory Flags#

DUNS number
783546109
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850868002025PreveLeak™ Surgical Sealant4 ml90042014-09-15
00850868002032PreveLeak™ Surgical Sealant5 ml90082014-09-15
00850868002049PreveLeak™ Surgical Sealant2.5 ml90072015-12-31
00850868002063PreveLeak™ Surgical Sealant2.5 ml90072014-09-15

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
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