FDA.reportPublic FDA data

Luke Replaceable Part

Primary DI
00859503006220
Brand
Luke Replaceable Part
Company
MOBIUS BIONICS LLC
Model
LU-12010-001
Device description
"CONVENIENCE KIT, FINGERNAILS AND SCREWSIncludes:LU-41115-001 Recloseable Bag, 1.5"" x 2"" 2MILDKLU-41005-20060 SCREW, CHEESE HEAD, MACHINE (SLOTTED), M2.0 X 0.40 X 6MM STAINLESS STEEL 8 (qty. 8)DKLU-41005-20050 SCREW, CHEESE HEAD, MACHINE (SLOTTED), M2.0 X 0.40 X 5MM STAINLESS STEEL 2 (qty. 2)DKLU-36352-001 FINGERNAIL, THUMBDKLU-36403-001 FINGERNAIL, PINKY DKLU-36407-001 FINGERNAIL, MIDDLE AND RING FINGERSDKLU-36434-001 FINGERNAIL, INDEX"
Published
2022-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PAEUpper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAEUpper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous ElectromyographyPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN120016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN120016000DEKA ARM SYSTEMDeka Integrated Solutions Corporation2014-05-09PAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859503006220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859503006220008595030062208595030062200859503006220

GMDN Terms#

Term, Definition table
TermDefinition
Myoelectric hand prosthesisA powered artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to replace the appearance and some of the function of the hand. The device moves as the result of a motor(s) that may be integral or proximally mounted with a mechanical link. The control of movement is achieved through amplified muscle action potentials from voluntary contracting muscle in the residual limb/trunk, transmitted via surface electrodes in the device that make contact with the skin, which turn on the motor to provide a function.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080216821
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859503006732Luke Replaceable PartLU-20360-0012019-04-18
00859503006015LUKE ArmLU-10112-0022016-10-21
00859503006022LUKE ArmLU-10122-0022016-10-21
00859503006039LUKE ArmLU-10311-0X22016-10-21
00859503006046LUKE ArmLU-10312-0X22016-10-21
00859503006053LUKE ArmLU-10321-0X22016-10-21
00859503006060LUKE ArmLU-10322-0X22016-10-21
00859503006077LUKE ArmLU-10511-XX22016-10-21
00859503006084LUKE ArmLU-10512-XX22016-10-21
00859503006091LUKE ArmLU-10521-XX22016-10-21
00859503006107LUKE ArmLU-10522-XX22016-10-21
00859503006114Luke Replaceable PartLU-20260-0012016-10-21
00859503006121Luke Replaceable PartLU-20264-0012016-10-21
00859503006138Luke Replaceable PartLU-20269-0012016-10-21
00859503006145Luke Replaceable PartLU-20272-0012016-10-21
00859503006152Luke Replaceable PartLU-20273-0012016-10-21
00859503006169Luke Replaceable PartLU-20273-0022016-10-21
00859503006176Luke Replaceable PartLU-20274-0012016-10-21
00859503006183Luke Replaceable PartLU-20275-0012016-10-21
00859503006190Luke Replaceable PartLU-20283-0012016-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859503006732Luke Replaceable PartMOBIUS BIONICS LLCPAE2019-04-18
00859503006725Luke Replaceable PartMOBIUS BIONICS LLCPAE2019-01-15
00859503006671Luke Replaceable PartMOBIUS BIONICS LLCPAE2017-02-14
00859503006688Luke Replaceable PartMOBIUS BIONICS LLCPAE2017-02-14
00859503006695Luke Replaceable PartMOBIUS BIONICS LLCPAE2017-02-14
00859503006015LUKE ArmMOBIUS BIONICS LLCPAE2016-10-21
00859503006022LUKE ArmMOBIUS BIONICS LLCPAE2016-10-21
00859503006039LUKE ArmMOBIUS BIONICS LLCPAE2016-10-21
00859503006046LUKE ArmMOBIUS BIONICS LLCPAE2016-10-21
00859503006053LUKE ArmMOBIUS BIONICS LLCPAE2016-10-21
00859503006060LUKE ArmMOBIUS BIONICS LLCPAE2016-10-21
00859503006077LUKE ArmMOBIUS BIONICS LLCPAE2016-10-21
00859503006084LUKE ArmMOBIUS BIONICS LLCPAE2016-10-21
00859503006091LUKE ArmMOBIUS BIONICS LLCPAE2016-10-21
00859503006107LUKE ArmMOBIUS BIONICS LLCPAE2016-10-21
00859503006114Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006121Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006138Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006145Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006152Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006169Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006176Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006183Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006190Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006206Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006213Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006237Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006244Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006251Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21
00859503006268Luke Replaceable PartMOBIUS BIONICS LLCPAE2016-10-21