FDA.reportPublic FDA data

ESPIRE

Primary DI
05056394326474
Brand
ESPIRE
Company
HUGH STEEPER LIMITED
Model
Espire Elbow Classic Plus- Left- Jet Black- Medial
Catalog number
EECP-LJMS
Published
2023-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IRDJoint, Elbow, External Limb Component, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRDJoint, Elbow, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056394326474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056394326474050563943264745056394326474

GMDN Terms#

Term, Definition table
TermDefinition
Body-powered elbow prosthesis, lockingAn 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 connecting straps/cables or other mechanism powered by the movement of body segments, or it moves as the result of a connection with another functional limb component. The position of the device can be maintained by a locking mechanism that is body- or externally-powered.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
210280350
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05063368529106BATTERY SYSTEMLITHIUM BATTERY CHARGERLIBCH2023-10-04
05063368529502BATTERY SYSTEM50MM KINISI SH WR HOUSINGMKSW502023-10-04
05063368529496BATTERY SYSTEM45MM KINISI SH WR HOUSINGMKSW452023-10-04
05063368529519BATTERY SYSTEM50MM KINISI SH WR HOUSING M12BBSW50-M122023-10-04
05063368529526Wrist45MM STEEPER FR HD PL KITSFW0452023-10-04
50633685291064BATTERY SYSTEMLITHIUM BATTERY CHARGERLIBCH2023-10-04
50633685295024BATTERY SYSTEM50MM KINISI SH WR HOUSINGMKSW502023-10-04
05055348200228S-CHARGES-Charger - Wall Charger KitSWC22002023-08-08
05055348248602PVC GloveTrueFinish ™ PVC Glove Childs Number# Colour# TG20/E22023-08-08
05055348249784PVC GloveTrueFinish ™ PVC Glove Male HD Number# Colour# TG104/E62023-08-08
05055348252708PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E82023-08-08
05056349561615PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E32023-08-08
05056349561622PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E52023-08-08
05056349561639PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E72023-08-08
05056349561646PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E92023-08-08
05056349563251PVC GloveTrueFinish ™ PVC Glove Childs Number# Colour# TG19/E32023-08-08
05056349563428PVC GloveTrueFinish ™ PVC Glove Male Number# Colour# TG2/E32023-08-08
05056349563473PVC GloveTrueFinish ™ PVC Glove Childs Number# Colour# TG20/E12023-08-08
05056349563725PVC GloveTrueFinish ™ PVC Glove Male Number# Colour# TG200/E22023-08-08
05056349563923PVC GloveTrueFinish ™ PVC Glove Male Number# Colour# TG201/E32023-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179880729CopperfitIdeavillage Products CorpIRD2025-02-04
00810179880309CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880316CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880323CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880330CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880347CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880354 CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880361CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880378CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880385CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880392CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880408 CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880415CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880422CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880446CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880453CopperfitIdeavillage Products CorpIRD2024-11-18
05055348200792Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348201218ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348227997Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348247742Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348247780ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348247797ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348248572Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348252920Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348262127ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348262134ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348262257Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348262288Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348201058ElbowHUGH STEEPER LIMITEDIRD2023-08-01
05055348201065ElbowHUGH STEEPER LIMITEDIRD2023-08-01