FDA.report

Typenex Wound Drainage

Primary DI
00812269030342
Brand
Typenex Wound Drainage
Company
TYPENEX MEDICAL LLC
Model
WD0503B
Device description
15 FR Round Fluted, Full with Bendable Trocar
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GBXCatheter, Irrigation
KGZAccessories, Catheter

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812269030342PackageGS110In Commercial Distribution
00812269030335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812269030342008122690303428122690303420812269030342
00812269030335008122690303358122690303350812269030335

GMDN Terms

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

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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00810050855457Rad ControlRT03022025-05-23
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20810050855734Microscope SlidesPS0202WXL2025-02-03
20810050855680Microscope SlidesPS0404W2025-01-21
00810050855631ThermoFlo®62412024-12-06
10810050855669ThermoFlo®60012024-11-20
20810050855673Microscope SlidesPS0201WXL2024-11-18

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