FDA.reportPublic FDA data

JEDMED

Primary DI
M6335329040
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
53-2904
Catalog number
53-2904
Device description
TROCAR & CANNULA SINUS 4MM
Published
2020-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KBGTrocar, Sinus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBGTrocar, SinusEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6335329040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ENT trocar bladeA rigid, surgical instrument with a sharp pyramidal or conical point used to puncture body cavities during ear/nose/throat (ENT) surgery. It can be assembled and used together with a compatible cannula (not included) filling its lumen, thereby allowing the introduction of this assembly; following puncture, the trocar blade is withdrawn. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
092987189
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6339982060JEDMED99-820699-82062023-02-03
M6339977070JEDMED99-770799-77072023-02-03
M6339977080JEDMED99-770899-77082023-02-03
M6339977090JEDMED99-770999-77092023-02-03
M6339977100JEDMED99-771099-77102023-02-03
M6339977110JEDMED99-771199-77112023-02-03
M6339977120JEDMED99-771299-77122023-02-03
M6339977400JEDMED99-774099-77402023-02-03
M6339977410JEDMED99-774199-77412023-02-03
M6339977420JEDMED99-774299-77422023-02-03
M6339977430JEDMED99-774399-77432023-02-03
M6339977450JEDMED99-774599-77452023-02-03
M6339977460JEDMED99-774699-77462023-02-03
M63399774610JEDMED99-7746-199-7746-12023-02-03
M6339977470JEDMED99-774799-77472023-02-03
M6339977480JEDMED99-774899-77482023-02-03
M6339977490JEDMED99-774999-77492023-02-03
M6339977500JEDMED99-775099-77502023-02-03
M6339978000JEDMED99-780099-78002023-02-03
M6339978100JEDMED99-781099-78102023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118131294LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2022-02-22
00888118131300LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2022-02-22
M6335325050JEDMEDJEDMED INSTRUMENT COMPANYKBG2020-09-21
M6335325290JEDMEDJEDMED INSTRUMENT COMPANYKBG2020-09-21
M6335329030JEDMEDJEDMED INSTRUMENT COMPANYKBG2020-09-21
00888118041289LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2020-06-19
00888118041340LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2020-06-19
00888118041357LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2020-06-19
00888118041371LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2020-06-19
00888118041623LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2020-06-19
00888118041630LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2020-06-19
00888118041678LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2020-06-19
00888118071958TROCARKLS-Martin L.P.KBG2018-09-26
00888118073402LEVEL ONEKLS-Martin L.P.KBG2018-09-26
00888118090300LEVEL ONEKLS-Martin L.P.KBG2018-09-26
00888118090324LEVEL ONEKLS-Martin L.P.KBG2018-09-26
00888118097217LEVEL ONEKLS-Martin L.P.KBG2018-09-26
00888118097644LEVEL ONEKLS-Martin L.P.KBG2018-09-26
00888118119162LEVEL ONEKLS-Martin L.P.KBG2018-09-26
00888118004895LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26
00888118006790LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26
00888118006806LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26
00888118006899LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26
00888118006905LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26
00888118073396LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26
00888118074966LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26
00888118076847LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26
00888118090263LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26
00888118090287LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26
00888118117922LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26