FDA.reportPublic FDA data

3.5 mm Reusable Trocars-Cannulae

Primary DI
00842102111679
Brand
3.5 mm Reusable Trocars-Cannulae
Company
FLEXBAR MACHINE CORPORATION
Model
92703-PY
Device description
Trocar-Cannula Set 3.5mm x 60mm, Pyramidal Tip
Published
2019-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FBMCannula And Trocar, Suprapubic, Non-Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBMCannula And Trocar, Suprapubic, Non-DisposableGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842102111679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102111679008421021116798421021116790842102111679

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic trocar blade, reusableA rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
047644935
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Sterilization required before use
true

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