FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704278552
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN014528
Catalog number
KM48259
Device description
LINEMAN PLIERS 8 1/2" MAXIMUM CAPACITY 1.6 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
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTCPLIERS, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTCPliers, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704278558Direct MarkingGS10
24026704278552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704278558040267042785584026704278558
2402670427855224026704278552

GMDN Terms#

Term, Definition table
TermDefinition
Wire cutterA heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length21.7Centimeter

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
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
true
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810189451537Surgical DesignSurgical Design, Inc.HTC2026-05-23
G149TBSB71180TBS BASICSACME ENTERPRISE.HTC2026-05-22
G149TBSB71190TBS BASICSACME ENTERPRISE.HTC2026-05-22
D9281301290SLOTTED SPONGE FORCEPS, 15CMW.H. Holden, Inc.HTC2026-01-05
03662663217651Posterior Cervical Removal InstrumentsHighridge Medical, LLCHTC2025-12-17
00840314270207gSourceGSOURCE LLCHTC2025-11-17
00840314270214gSourceGSOURCE LLCHTC2025-11-17
00885556908860EVOSSmith & Nephew, Inc.HTC2025-11-11
00885556911570EVOSSmith & Nephew, Inc.HTC2025-11-11
00885556911587EVOSSmith & Nephew, Inc.HTC2025-11-11
00841336106109Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106116Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106123Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106130Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
08033390289061ArTTLIMACORPORATE SPAHTC2025-09-25
B356KE334280American MedicalsAmerican MedicalsHTC2025-09-15
B356KJ522130American MedicalsAmerican MedicalsHTC2025-09-12
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00841435111127TecometTECOMET INC.HTC2025-08-27
00841435111134TecometTECOMET INC.HTC2025-08-27
00841435111141TecometTECOMET INC.HTC2025-08-27
00841435111158TecometTECOMET INC.HTC2025-08-27
00841435111165TecometTECOMET INC.HTC2025-08-27
00841435111172TecometTECOMET INC.HTC2025-08-27
00841435111189TecometTECOMET INC.HTC2025-08-27
00841435111202TecometTECOMET INC.HTC2025-08-27
00841435118263TecometTECOMET INC.HTC2025-08-27
00841435118287TecometTECOMET INC.HTC2025-08-27
00841435118317TecometTECOMET INC.HTC2025-08-27