FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704271331
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN013909
Catalog number
KM46601
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
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704271337Direct MarkingGS10
24026704271331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704271337040267042713374026704271337
2402670427133124026704271331

GMDN Terms#

Term, Definition table
TermDefinition
Amputation knifeA hand-held manual surgical instrument with a handle and a heavy single-edged or double-edged blade, of various shapes and sizes, used in surgery for the amputation of a limb. It is typically a one-piece instrument made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length22.9Centimeter

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
14026704945310RUSCH116411642026-07-24
14026704945327RUSCH116511652026-07-24
14026704945334RUSCH116611662026-07-24
14026704945341RUSCH116711672026-07-24
14026704945358RUSCH116811682026-07-24
14026704945365RUSCH116911692026-07-24
14026704945372RUSCH117011702026-07-24
14026704945389RUSCH117111712026-07-24
14026704930651QUIKCLOT1831832026-07-17
14026704930675QUIKCLOT1881882026-07-17
14026704930736QUIKCLOT4594592026-07-17
10801902213188ARROWIPN927188DLX-200-CURV2026-07-23
10841156108908TRAPLINERIPN91750955672026-07-23
10841156111311LANGSTONIPN93013555402026-07-23
14026704944450RUSCH2205000602205000602026-07-23
14026704945402RUSCH2204001402204001402026-07-23
14026704945419RUSCH2204001602204001602026-07-23
14026704945426RUSCH2205000802205000802026-07-23
14026704945617RUSCH2204000802204000802026-07-23
14026704945624RUSCH2204001002204001002026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B504OM22963414S70StrykerProvisionGFA2026-07-20
B504OM41251470900StrykerProvisionGFA2026-07-20
B504OM50711850Conmed LinvatecProvisionGFA2026-07-20
B504OM51003372330StrykerProvisionGFA2026-07-20
08800053401142SharkCutTechcord co.,LtdGFA2024-04-15
08800053401159SharkCutTechcord co.,LtdGFA2024-04-15
08800053401166SharkCutTechcord co.,LtdGFA2024-04-15
08800053401173SharkCutTechcord co.,LtdGFA2024-04-15
08800053401180SharkCutTechcord co.,LtdGFA2024-04-15
08800053401197SharkCutTechcord co.,LtdGFA2024-04-15
08800053401203SharkCutTechcord co.,LtdGFA2024-04-15
08800053401210SharkCutTechcord co.,LtdGFA2024-04-15
08800053401227SharkCutTechcord co.,LtdGFA2024-04-15
08800053401234SharkCutTechcord co.,LtdGFA2024-04-15
08800053401241SharkCutTechcord co.,LtdGFA2024-04-15
08800053401258SharkCutTechcord co.,LtdGFA2024-04-15
08800053401289SharkCutTechcord co.,LtdGFA2024-04-15
08800053401296SharkCutTechcord co.,LtdGFA2024-04-15
08800053401265SharkCutTechcord co.,LtdGFA2024-04-12
08800053401272SharkCutTechcord co.,LtdGFA2024-04-12
07613327576566PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576672PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576696PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576719PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576733PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576740PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327512342CrossBladeSTRYKER CORPORATIONGFA2021-06-21
07613327512311CrossBladeSTRYKER CORPORATIONGFA2020-11-09
07613327512328CrossBladeSTRYKER CORPORATIONGFA2020-11-09
07613327512335CrossBladeSTRYKER CORPORATIONGFA2020-11-09