FDA.reportPublic FDA data

Typenex Wound Drainage

Primary DI
00812269030311
Brand
Typenex Wound Drainage
Company
TYPENEX MEDICAL LLC
Model
WD0401T
Device description
7 mm Flat Perforated, Full with Trocar
Published
2022-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation
KGZAccessories, Catheter

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812269030328PackageGS110In Commercial Distribution
00812269030311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812269030328008122690303288122690303280812269030328
00812269030311008122690303118122690303110812269030311

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600850213
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810050855850Microscope SlidesPS0404G2026-05-14
10810050855867Microscope SlidesPS0404L2026-05-14
10810050855874Microscope SlidesPS0404N2026-05-14
10810050855881Microscope SlidesPS0404P2026-05-14
10810050855898Microscope SlidesPS0404Y2026-05-14
10810050855904Embedding CassetteEC0616YXT-LASER2026-05-14
10810050855911Embedding CassetteEC0616PXT-LASER2026-05-14
10810050855928Embedding CassetteEC0616WXT-LASER2026-05-14
10810050855935Embedding CassetteEC0616EXT-LASER2026-05-14
10810050855843Rad ControlRT0301XBA2026-05-06
10810050855836Microscope SlidesLC0105B2026-03-23
20810050855833Microscope SlidesLC0105B2026-03-23
B050SL1000020Sterile LabelsSL-1000022026-03-17
B050SL1000021Sterile LabelsSL-1000022026-03-17
00810050851923Specimen Collection SwabSW0202SW02022020-06-01
00810050851909Specimen Collection SwabSW0102SW01022020-06-01
00810050852388Anterior Nasal SwabSW0302SW03022020-08-20
00810050855815ThermoFlo®60612026-01-26
00810050855808Typenex Introducer SetMS2335S2025-11-17
10810050855805Typenex Introducer SetMS2335S2025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459435201MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
10704411017882AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
10192253053609DevonCardinal Health 200, LLCKGZ2025-03-25
10192253042023DevonCardinal Health 200, LLCKGZ2025-03-07
10192253042030DevonCardinal Health 200, LLCKGZ2025-03-07
10080196995998MEDLINEMEDLINE INDUSTRIES, INC.GBX2024-12-12
10080196128839MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10193489068245NAMICMEDLINE INDUSTRIES, INC.KGZ2023-12-21
10193489068108MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068115MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068122MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140187MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140194MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10653160291527CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKGZ2022-01-01
10653160235132Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGZ2021-09-02
10195594230456CARDINAL HEALTHCardinal Health 200, LLCKGZ2021-08-16
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