FDA.reportPublic FDA data

MC Seal Ring Kit, Medium/Large, Sand

Primary DI
09421037390451
Brand
MC Seal Ring Kit, Medium/Large, Sand
Company
TASKA PROSTHETICS LIMITED
Model
195-20-004-SN
Published
2025-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISZUnit, Wrist, External Limb Component, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISZUnit, Wrist, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421037390451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421037390451094210373904519421037390451

GMDN Terms#

Term, Definition table
TermDefinition
Myoelectric wrist prosthesisA powered artificial substitute for a missing wrist used as part of an upper-limb external prosthetic system and designed to restore some of the function of the joint. The device moves as the result of external motor power applied directly or via a connection with another functional limb component. Surface electrodes embedded in the device make contact with the skin and amplify muscle action potentials from voluntary contracting muscle in the residual limb/trunk, which turns on the motor to provide a function.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
591366609
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421037390413TASKA PowerCore System, BlackTASKA-21AB312026-01-07
09421037390420TASKA PowerCore System, SandTASKA-21AC312026-01-07
09421906785005TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP WhiteTASKA-B1CA21-U12026-01-07
09421906785012TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP BlackTASKA-B1CB21-U12026-01-07
09421906785029TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP SandTASKA-B1CC21-U12026-01-07
09421906785036TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD WhiteTASKA-B1FA21-U12026-01-07
09421906785043TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD BlackTASKA-B1FB21-U12026-01-07
09421906785050TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD SandTASKA-B1FC21-U12026-01-07
09421906785067TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP WhiteTASKA-B2CA21-U12026-01-07
09421906785074TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP BlackTASKA-B2CB21-U12026-01-07
09421906785081TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP SandTASKA-B2CC21-U12026-01-07
09421906785098TASKA HandGen2 Myoelectric Hand - 8 1/4 LH QWD WhiteTASKA-B2FA21-U12026-01-07
09421906785104TASKA HandGen2 Myoelectric Hand - 8 1/4 LH QWD BlackTASKA-B2FB21-U12026-01-07
09421906785111TASKA HandGen2 Myoelectric Hand - 8 1/4 LH QWD SandTASKA-B2FC21-U12026-01-07
09421906785128TASKA HandGen2 Myoelectric Hand - 7 3/4 RH LP WhiteTASKA-C1CA21-U12026-01-07
09421906785135TASKA HandGen2 Myoelectric Hand - 7 3/4 RH LP BlackTASKA-C1CB21-U12026-01-07
09421906785142TASKA HandGen2 Myoelectric Hand - 7 3/4 RH LP SandTASKA-C1CC21-U12026-01-07
09421906785159TASKA HandGen2 Myoelectric Hand - 7 3/4 RH QWD WhiteTASKA-C1FA21-U12026-01-07
09421906785166TASKA HandGen2 Myoelectric Hand - 7 3/4 RH QWD BlackTASKA-C1FB21-U12026-01-07
09421906785173TASKA HandGen2 Myoelectric Hand - 7 3/4 RH QWD SandTASKA-C1FC21-U12026-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429650884Explorer Hold Lock Modulemacu4 GmbHISZ2026-03-23
04262429650006Explorer Bike Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650013Explorer Bike Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650020Explorer Ball Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650037Explorer Ball Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650044Explorer Ball Module SML without spacermacu4 GmbHISZ2025-11-23
04262429650051Explorer Ball Module SML with spacermacu4 GmbHISZ2025-11-23
04262429650068Explorer Swim Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650075Explorer Swim Module SML without spacermacu4 GmbHISZ2025-11-23
04262429650082Explorer Twin Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650099Explorer Twin Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650105Explorer Twin Module LRG without spacermacu4 GmbHISZ2025-11-23
04262429650112Explorer Twin Module LRG with spacermacu4 GmbHISZ2025-11-23
04262429650136Explorer Ring STDmacu4 GmbHISZ2025-11-23
04262429650143Explorer Pinch Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650150Explorer Pinch Module spacermacu4 GmbHISZ2025-11-23
04262429650297Explorer Ring EXPmacu4 GmbHISZ2025-11-23
04262429650303Explorer Hold Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650310Explorer Hold Module spacermacu4 GmbHISZ2025-11-23
09421037390383Low Profile Lamination Kit, CX, 50mm TASKA PROSTHETICS LIMITEDISZ2025-07-29
09421037390505TASKA Seal Ring Kit, 50mm, SandTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785425MC Seal Ring Kit, Medium/Large, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785432TASKA Seal Ring Kit, 50mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785944MC Seal Ring Kit, Small, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785951MC Seal Ring Kit, Small, Sand TASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785982TASKA Seal Ring Kit, 45mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785999TASKA Seal Ring Kit, 45mm, SandTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421037390390TASKA Lamination Collar Kit (6-band), 50mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-28
09421037390406TASKA Lamination Collar Kit (6-band), 50mm, Sand TASKA PROSTHETICS LIMITEDISZ2025-07-28
09421906785913TASKA Lamination Collar Kit (6-band), 45mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-25