FDA.reportPublic FDA data

LEVEL ONE TRANSBUCCAL

Primary DI
00888118041623
Brand
LEVEL ONE TRANSBUCCAL
Company
KLS-Martin L.P.
Model
25-478-00-07
Device description
CANNULA, RASSE, W/HANDLE
Published
2020-06-19
Public version status
Update
Distribution status
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
00888118041623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118041623008881180416238881180416230888118041623

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00888118086037SILICONE MAT55-348-01-012020-06-19
00888118125729TRAY55-804-25-012020-06-19
00888118003119CARRIER00-105-92-072018-09-26
00888118006974CURETTE01-500-01-072018-09-26
00888118006981CURETTE01-500-02-072018-09-26
00888118006998CURETTE01-500-03-072018-09-26
00888118008626CALIPER04-407-20-072018-09-26
00888118009012SCOPE HOLDER ARM07-001-42-072016-09-20
00888118009029SCOPE HOLDER CLAMP07-001-43-072016-09-20
00888118009050SCOPE HOLDER ARM07-001-49-072016-09-20
00888118022950PHLEBEXTRACTOR16-249-02-072018-09-26
00888118022967PHLEBEXTRACTOR16-249-03-072018-09-26
00888118022981STRIPPER16-251-02-012018-09-26
00888118022998STRIPPER16-251-03-012018-09-26
00888118023001STRIPPER16-251-04-012018-09-26
00888118023018STRIPPER16-251-06-012018-09-26
00888118023025STRIPPER16-251-07-012018-09-26
00888118023032STRIPPER16-251-08-012018-09-26
00888118023049STRIPPER16-251-10-012018-09-26
00888118023056STRIPPER16-251-14-012018-09-26

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
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