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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

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
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
00888118117984LEVEL ONE TRANSBUCCALKLS-Martin L.P.KBG2018-09-26