FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704281569
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN014778
Catalog number
KM49268
Device description
"LEXER-MINI CHISEL 7"", 12 MILLIMETER"
Published
2018-09-15
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
FZOCHISEL, SURGICAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704281565Direct MarkingGS10
24026704281569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704281565040267042815654026704281565
2402670428156924026704281569

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length17.8Centimeter
Width27Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806373887697BENCOX Surgical InstrumentsCorentec Co., LtdFZO2026-04-10
10649111080036Sklar®SKLAR CORPORATIONFZO2019-02-25
10649111010613Sklar®SKLAR CORPORATIONFZO2019-02-12
10649111052699Sklar®SKLAR CORPORATIONFZO2018-11-26
10381780495215Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-24
10381780495314Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-24
10381780509325Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-23
10649111066283Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111066733Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067198Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067556Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067938Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111068317Sklar®SKLAR CORPORATIONFZO2018-10-22
10381780506874Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-17
10649111095245Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095443Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095559Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095825Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096013Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096112Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096341Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096556Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096679Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096822Sklar®SKLAR CORPORATIONFZO2018-09-27
10603295084020SIGMADEPUY (IRELAND)FZO2018-09-24
10603295107798NADEPUY ORTHOPAEDICS, INC.FZO2018-09-24
10603295122715NADEPUY (IRELAND)FZO2018-09-24
10381780499176Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18
10381780499183Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18
10381780499190Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18