Home GUDID 30705031133109 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 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 20705031133102 Package GS1 4 Not in Commercial Distribution 30705031133109 Package GS1 4 Not in Commercial Distribution 10705031133105 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20705031133102 20705031133102 30705031133109 30705031133109 10705031133105 10705031133105
GMDN Terms# Term, Definition table Term Definition Skin-approximation adhesive A 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 Type Low High Condition Special Storage Condition, Specify 0 0 Do Not Resterilize Storage Environment Temperature 0 25 Degrees Celsius Storage Environment Temperature 0 77 Degrees Fahrenheit
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 25413765583524 PREVELEAK SURGICAL SEALANT Baxter Healthcare Corporation NBE 2022-02-22 25413765583586 PREVELEAK SURGICAL SEALANT Baxter Healthcare Corporation NBE 2022-02-22 25413765583593 PREVELEAK SURGICAL SEALANT Baxter Healthcare Corporation NBE 2021-06-01 25413765583609 PREVELEAK SURGICAL SEALANT Baxter Healthcare Corporation NBE 2021-06-01 35413765583415 COSEAL SPRAY SET BAXTER HEALTHCARE CORPORATION NBE 2020-09-30 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 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 INTERNATIONAL INC. 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 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 20801741010037 Progel™ Applicator Spray Tips NEOMEND, INC. NBE 2014-09-12 10801741010009 Progel™Extended Applicator Spray Tip NEOMEND, INC. NBE 2014-09-12 10801741010016 Progel™Extended Applicator Spray Tip NEOMEND, INC. NBE 2014-09-12 10801741010023 Progel™ Pleural Air Leak Sealant NEOMEND, INC. NBE 2014-09-12