FDA.report

Typenex Wound Drainage

Primary DI
10810050853733
Brand
Typenex Wound Drainage
Company
TYPENEX MEDICAL LLC
Model
WD1009
Device description
12 FR SILICONE T-TUBE
Published
2021-08-13
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

Related Records

Contact Domains

Product Codes

CodeName
GBXCatheter, Irrigation
KGZAccessories, Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810050853733PackageGS120In Commercial Distribution
00810050853736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005085373310810050853733
00810050853736008100508537368100508537360810050853736

GMDN Terms

TermDefinition
Closed-wound drainA sterile, tube-like 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 wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Device Sizes

TypeValueUnit
Outer Diameter4Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
866-897-3639mchoquette@typenex.com

Regulatory Flags

DUNS number
600850213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20810050855680Microscope SlidesPS0404W2025-01-21
00810050855631ThermoFlo®62412024-12-06
10810050855669ThermoFlo®60012024-11-20
20810050855673Microscope SlidesPS0201WXL2024-11-18

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