FDA.report

Espire Elbow Pro

Primary DI
00841747183232
Brand
Espire Elbow Pro
Company
COLLEGE PARK INDUSTRIES, INC.
Model
EEP RSS IBT
Device description
Espire Elbow Pro, Right, Silver, Small, IBT
Published
2020-07-17
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

Related Records

Contact Domains

Product Codes

CodeName
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841747183232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841747183232008417471832328417471832320841747183232

GMDN Terms

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

Contacts

PhoneEmail
1-800-728-7950orders@college-park.com

Regulatory Flags

DUNS number
623191137
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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