FDA.reportPublic FDA data

Espire Elbow Hybrid

Primary DI
00841747183638
Brand
Espire Elbow Hybrid
Company
COLLEGE PARK INDUSTRIES, INC.
Model
EEH L001LD IBT
Device description
Espire Elbow Hybrid, Left, Black Carbon Finish, Lateral Dial, Standard, IBT
Published
2020-06-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841747183638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841747183638008417471836388417471836380841747183638

GMDN Terms#

Term, Definition table
TermDefinition
Myoelectric elbow prosthesisA powered artificial substitute for a missing elbow 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

Contacts#

Phone, Email table
PhoneEmail
1-800-728-7950orders@college-park.com

Regulatory Flags#

DUNS number
623191137
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195411492992Terrain VSTN VS LBEN 21 D12026-08-27
00195411493005Terrain VSTN VS LBEN 21 D22026-08-27
00195411493012Terrain VSTN VS LBEN 21 D32026-08-27
00195411493029Terrain VSTN VS LBEN 21 D42026-08-27
00195411493036Terrain VSTN VS LBEN 21 D52026-08-27
00195411493043Terrain VSTN VS LBEN 21 D62026-08-27
00195411493050Terrain VSTN VS LBEN 21 D72026-08-27
00195411493067Terrain VSTN VS LBEN 21 D82026-08-27
00195411493074Terrain VSTN VS LBEN 22 D12026-08-27
00195411493081Terrain VSTN VS LBEN 22 D22026-08-27
00195411493098Terrain VSTN VS LBEN 22 D32026-08-27
00195411493104Terrain VSTN VS LBEN 22 D42026-08-27
00195411493111Terrain VSTN VS LBEN 22 D52026-08-27
00195411493128Terrain VSTN VS LBEN 22 D62026-08-27
00195411493135Terrain VSTN VS LBEN 22 D72026-08-27
00195411493142Terrain VSTN VS LBEN 22 D82026-08-27
00195411493159Terrain VSTN VS LBEN 23 D12026-08-27
00195411493166Terrain VSTN VS LBEN 23 D22026-08-27
00195411493173Terrain VSTN VS LBEN 23 D32026-08-27
00195411493180Terrain VSTN VS LBEN 23 D42026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08