FDA.reportPublic FDA data

Medaxis LLC

Primary DI
10850038863095
Brand
Medaxis LLC
Company
Directmed, Inc.
Model
2000.0301
Device description
EN debriton + connecting Tube / SP debriton + tubo de conexion
Published
2025-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850038863095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085003886309510850038863095

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Regulatory Flags#

DUNS number
969484237
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850038863098Medaxis LLC2000.03012025-11-06
00850038863203Directmed, Inc.DM-1162025-07-11
10850038863200Directmed, Inc.DM-1162025-07-11
10850038863187Grace Medical, Inc.SP-30002024-11-18
10850038863194Grace Medical, Inc.SP-40002024-11-18
00850038863180Grace Medical, Inc.SP-30002024-11-18
00850038863197Grace Medical, Inc.SP-40002024-11-18
00850038863173Directmed, Inc.BMS-2135.172024-10-31
10850038863170Directmed, Inc.BMS-2135.172024-10-31
00850038863166DirectMed, Inc. SM-0072024-05-03
10850038863163DirectMed, Inc. SM-0072024-05-03
00850038863036Fresnius Kabi AGFK20251E2023-10-31
00850038863043Fresnius Kabi AGFK20255E2023-10-31
00850038863050Fresnius Kabi AGFK50030S2023-10-31
00850038863067Fresnius Kabi AGFK50060S2023-10-31
00850038863074OTOMED, INC.SP-30002023-10-31
00850038863081OTOMED, INC.SP-40002023-10-31
00850038863104Directmed, Inc.PME007B2023-10-31
00850038863111Directmed, Inc.PME007NB2023-10-31
00850038863128HMG Distribution LLCCV12023-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196995998MEDLINEMEDLINE INDUSTRIES, INC.GBX2024-12-12
10080196128839MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10801902210408ARROWTELEFLEX INCORPORATEDGBX2022-11-09
10801902194005ARROWTELEFLEX INCORPORATEDGBX2022-11-08
08034139292823Thoracic Catheter, Straight Fr 18REDAX SPAGBX2021-05-07
08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07
08034139292861Thoracic Catheter, Straight Fr 30REDAX SPAGBX2021-05-07
08034139292878Thoracic Catheter, Straight Fr 33REDAX SPAGBX2021-05-07
08034139293806Thoracic Catheter, Angled Fr 30REDAX SPAGBX2021-05-07
08034139293813Thoracic Catheter, Angled Fr 33REDAX SPAGBX2021-05-07
08034139294544Flat Drain 3/4 type Jackson-Pratt 4x10 mmREDAX SPAGBX2021-05-07
08034139294568Flat Drain type Jackson-Pratt 4x10 mmREDAX SPAGBX2021-05-07
08034139294575Flat Drain type Jackson-Pratt w/trocar 4x10 mmREDAX SPAGBX2021-05-07
08034139294582Flat Drain type Jackson-Pratt 4x13 mmREDAX SPAGBX2021-05-07
08034139294599Flat Drain type Jackson-Pratt w/trocar 4x13 mmREDAX SPAGBX2021-05-07
08034139294629Round Drain type Jackson-Pratt Fr 7REDAX SPAGBX2021-05-07
08034139294643Round Drain type Jackson-Pratt Fr 10REDAX SPAGBX2021-05-07
08034139294650Round Drain type Jackson-Pratt w/trocar Fr 10REDAX SPAGBX2021-05-07
08034139294698Round Drain type Jackson-Pratt w/trocar Fr 15REDAX SPAGBX2021-05-07
08034139294933Spiral Drain Round Fluted Drain w/trocar Fr 10REDAX SPAGBX2021-05-07
08034139294940Spiral Drain Round Fluted Drain w/trocar Fr 15REDAX SPAGBX2021-05-07
08034139294964Spiral Drain Round Fluted Drain w/trocar Fr 12REDAX SPAGBX2021-05-07
08034139294971Spiral Drain Round Fluted Drain Fr 7REDAX SPAGBX2021-05-07
08034139295008Spiral Drain Round Fluted Drain Fr 10REDAX SPAGBX2021-05-07
08034139295022Spiral Drain Round Fluted Drain Fr 15REDAX SPAGBX2021-05-07
08034139295039Spiral Drain Round Fluted Drain Fr 19REDAX SPAGBX2021-05-07
08034139295053Spiral Drain Round Fluted Drain Fr 24REDAX SPAGBX2021-05-07
08034139295060Flat Fluted Drain 4x10 mmREDAX SPAGBX2021-05-07