Home GUDID 25413765583524 PREVELEAK SURGICAL SEALANT
Primary DI 25413765583524
Brand PREVELEAK SURGICAL SEALANT
Company Baxter Healthcare Corporation
Model ADS201807
Catalog number ADS201807
Device description The delivery tip (10 pack) is a sterile, non-pyrogenic, single-use accessory device for use with the PREVELEAK family of products.
Published 2022-02-22
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 Product Codes# Code, Name table Code Name NBE Sealant, polymerizing
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NBE Sealant, Polymerizing Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 25413765583524 Package GS1 10 In Commercial Distribution 05413765583520 Primary GS1 0 75413765583529 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 25413765583524 25413765583524 05413765583520 05413765583520 5413765583520 75413765583529 75413765583529
GMDN Terms# Term, Definition table Term Definition Open-surgery adhesive/sealant applicator, dual-channel A sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstruction). The device, also known as a surgical sealant dispenser (SSD), is typically made of flexible metal or synthetic material, and has a connector at one end to attach a compatible dispensing device (e.g., a dual-component syringe). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 117472302 Device count 10 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 true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05413765583520 PREVELEAK SURGICAL SEALANT Baxter Healthcare Corporation NBE 2022-02-22 05413765583582 PREVELEAK SURGICAL SEALANT Baxter Healthcare Corporation NBE 2022-02-22 25413765583586 PREVELEAK SURGICAL SEALANT Baxter Healthcare Corporation NBE 2022-02-22 05413765583599 PREVELEAK SURGICAL SEALANT Baxter Healthcare Corporation NBE 2021-06-01 05413765583605 PREVELEAK SURGICAL SEALANT Baxter Healthcare Corporation NBE 2021-06-01 25413765583593 PREVELEAK SURGICAL SEALANT Baxter Healthcare Corporation NBE 2021-06-01 25413765583609 PREVELEAK SURGICAL SEALANT Baxter Healthcare Corporation NBE 2021-06-01 05413765583414 COSEAL SPRAY SET BAXTER HEALTHCARE CORPORATION NBE 2020-09-30 35413765583415 COSEAL SPRAY SET BAXTER HEALTHCARE CORPORATION NBE 2020-09-30 10801741099370 Tridyne NEOMEND, INC. NBE 2018-10-31 00801741099366 Tridyne NEOMEND, INC. NBE 2018-10-31 00801741099380 Tridyne NEOMEND, INC. NBE 2018-10-31 20801741099377 Tridyne™ Vascular Sealant Standard Spray Tips NEOMEND, INC. NBE 2018-10-31 10801741099363 Tridyne™ Vascular Sealant NEOMEND, INC. NBE 2018-10-31 10801741099387 Tridyne™ Vascular Sealant Extended Spray Tips NEOMEND, INC. NBE 2018-10-31 00085412083322 Coseal Surgical Sealant Replacement Applicator BAXTER HEALTHCARE CORPORATION NBE 2017-10-09 50085412083327 Coseal Surgical Sealant Replacement Applicator BAXTER HEALTHCARE CORPORATION NBE 2017-10-09 00085412083339 Coseal Surgical Sealant Extended Applicator BAXTER HEALTHCARE CORPORATION NBE 2017-10-09 00085412087788 Coseal Spray Set Baxter Healthcare SA NBE 2017-03-23 00850868002049 PreveLeak™ Surgical Sealant Tenaxis Medical, Inc. NBE 2015-12-31 00850868002056 PreveLeak™ 10 pack Tips Tenaxis Medical, Inc. NBE 2015-12-31 05413765404627 Coseal Surgical Sealant BAXTER HEALTHCARE CORPORATION NBE 2015-06-10 05413765404634 Coseal Surgical Sealant BAXTER HEALTHCARE CORPORATION NBE 2015-05-05 05413765404610 Coseal Surgical Sealant BAXTER HEALTHCARE CORPORATION NBE 2015-05-04 10705031133105 ETHICON OMNEX Ethicon Inc. NBE 2014-09-20 30705031133109 ETHICON OMNEX ETHICON INC. NBE 2014-09-20 00850868002025 PreveLeak™ Surgical Sealant Tenaxis Medical, Inc. NBE 2014-09-15 00850868002032 PreveLeak™ Surgical Sealant Tenaxis Medical, Inc. NBE 2014-09-15 00850868002063 PreveLeak™ Surgical Sealant Tenaxis Medical, Inc. NBE 2014-09-15 10801741010030 Progel NEOMEND, INC. NBE 2014-09-12
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