FDA.reportPublic FDA data

Penfield Elevator

Primary DI
04250337120490
Brand
Penfield Elevator
Company
Joimax GmbH
Model
THE154575
Catalog number
THE154575
Device description
Penfield Elevator blunt
Published
2023-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFIOsteotome, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337120490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337120490042503371204904250337120490

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Microwave Radiation

Contacts#

Phone, Email table
PhoneEmail
+497212551407010info@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337117384video lensCSFHD01COVZCSFHD01COVZ2022-12-30
04260744830561Fibre optic cableCSLC0348CSLC03482022-12-30
04260744831865Fibre optic cableCSLC0252CSLC02522022-12-30
04250337119876Sterilisation trayJSBDSST4680JSBDSST46802022-12-30
04250337110040intENTS®TNC582810GTNC582810G2022-12-30
04250337110057MultiZYTE®TNC582814GTNC582814G2022-12-30
04250337110064iLESSYS®TNC582820RTNC582820R2022-12-30
04250337113041TESSYS®TNC582820TNC5828202022-12-30
04250337117537tubTNC5828100TNC58281002022-12-30
04250337117544tubTNC5828135TNC58281352022-12-30
04250337117551tubTNC5828150TNC58281502022-12-30
04250337117568tubTNC5828200TNC58282002022-12-30
04250337117575iLESSYS®TNC5828CLTNC5828CL2022-12-30
04250337117582iLESSYS®TNC5828ILTNC5828IL2022-12-30
04250337117599iLESSYS®TNC5828MLTNC5828ML2022-12-30
04250337117605iLESSYS®TNC5828NLTNC5828NL2022-12-30
04250337117612iLESSYS®TNC5828TLTNC5828TL2022-12-30
04250337117827iLESSYS®TNC5828ALTNC5828AL2022-12-30
04250337120759deflectorJSBS311509JSBS3115092025-07-25
04250337120766deflectorJSBS311512JSBS3115122025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780408567Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408574Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408581Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408680Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408703Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408710Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408727Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408734Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408741Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408758Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408765Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408772Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780188087Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188094Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188100Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188117Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188124Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188131Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188148Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188155Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188162Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188179Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188186Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188193Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188209Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188216Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188223Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188230Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188346Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188353Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02