FDA.reportPublic FDA data

LEVEL ONE

Primary DI
00888118097644
Brand
LEVEL ONE
Company
KLS-Martin L.P.
Model
99-571-60-01
Published
2018-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00888118097644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118097644008881180976448881180976440888118097644

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic trocar blade, reusableA rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118126528LEVEL ONE CMF, STERILE50-774-24-712020-04-22
00888118006530LEVEL ONE CMF01-405-08-092016-03-24
00888118034717LEVEL ONE CMF25-001-13-092016-03-24
00888118034731LEVEL ONE CMF25-002-13-092016-03-24
00888118034748LEVEL ONE CMF25-003-02-092016-03-24
00888118034816LEVEL ONE NEURO, STERILE25-003-10-712016-03-23
00888118034915LEVEL ONE NEURO25-003-21-092016-03-24
00888118035028LEVEL ONE NEURO25-005-12-092016-03-24
00888118035042LEVEL ONE CMF25-006-09-092016-03-24
00888118035721LEVEL ONE CMF25-010-03-092016-03-24
00888118035752LEVEL ONE CMF25-010-08-092016-03-24
00888118035882LEVEL ONE NEURO25-015-04-092016-03-24
00888118035912LEVEL ONE NEURO25-015-06-092016-03-24
00888118035943LEVEL ONE NEURO25-015-08-092016-03-24
00888118035974LEVEL ONE NEURO25-016-06-092016-03-24
00888118036018LEVEL ONE NEURO25-016-10-092016-03-24
00888118036049LEVEL ONE CMF25-017-04-092016-03-24
00888118036056LEVEL ONE CMF25-017-06-092016-03-24
00888118036063LEVEL ONE CMF25-017-08-092016-03-24
00888118036148LEVEL ONE CMF25-020-24-092016-03-24

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
M6335329040JEDMEDJEDMED INSTRUMENT COMPANYKBG2020-09-21
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
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