FDA.reportPublic FDA data

Typenex Wound Drainage

Primary DI
00810050852296
Brand
Typenex Wound Drainage
Company
TYPENEX MEDICAL LLC
Model
WD0301
Device description
7 FR Round Perforated, Full
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
KGZAccessories, Catheter

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810050852293PackageGS110In Commercial Distribution
00810050852296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005085229310810050852293
00810050852296008100508522968100508522960810050852296

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.

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
00810050851954Typenex Introducer SetMS17122020-06-09
00810050853460Typenex Introducer SetMS1235S2021-01-26
00810050853491Typenex Introducer SetMS1335S2021-01-26
00810050853514Typenex Introducer SetMS1835S2021-01-26
00810050853774Typenex Introducer SetMS19122021-08-11
00810050853804Typenex Introducer SetMS21122021-08-11
00810050853811Typenex Introducer SetMS20122021-08-11
00810050853842Typenex Introducer SetMS22122021-08-11
00810050855808Typenex Introducer SetMS2335S2025-11-17
00812269032957Typenex Introducer SetMS02362019-09-18
00812269032971Typenex Introducer SetMS03362019-09-18
00812269032995Typenex Introducer SetMS04362019-09-18
00812269033015Typenex Introducer SetMS05362019-09-18
00812269033039Typenex Introducer SetMS06362019-09-18
00812269033053Typenex Introducer SetMS02442019-09-18
00812269033077Typenex Introducer SetMS03442019-09-18
00812269033091Typenex Introducer SetMS04442019-09-18
00812269033114Typenex Introducer SetMS1144S2019-09-18
00812269033138Typenex Introducer SetMS1244S2019-09-18
00812269033152Typenex Introducer SetMS1344S2019-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976712970341Hemo Luer LockMicro-Energy Medical Technology Co., LtdKGZ2026-07-13
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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
30382904275656BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
30382904275618BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275625BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275632BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275649BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275601BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-16
00815634021761FibrijetMicromedics, Inc.KGZ2024-06-18
00628725047638Safety Drain line adapterCanadian Hospital Specialties LimitedKGZ2024-06-17
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
M710WW12K0Wire Watch™BIOTEX, INC.KGZ2023-07-31
10850005416002MedDrainARMM INC.KGZ2023-06-08
10850005416019MedDrainARMM INC.KGZ2023-06-08
10850005416033MedDrainARMM INC.KGZ2023-06-08
10850005416071MedDrainARMM INC.KGZ2023-06-08
10850082007896MedDrainARMM INC.KGZ2023-06-08
10850082007902MedDrainARMM INC.KGZ2023-06-08
10850082007919MedDrainARMM INC.KGZ2023-06-08
10850082007995MedDrainARMM INC.KGZ2023-06-08