FDA.report

Espire Elbow Hybrid

Primary DI
00841747183447
Brand
Espire Elbow Hybrid
Company
COLLEGE PARK INDUSTRIES, INC.
Model
EEH RSMS IBT
Device description
Espire Elbow Hybrid, Right, Silver, Medial Dial, Small, IBT
Published
2020-06-08
Public version status
Update
Distribution status
Not 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
00841747183447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841747183447008417471834478417471834470841747183447

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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00841747186929Endoskeletal ComponentsTA WT430 302025-05-28
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00841747184086SterlingSLK G9L US22024-11-01
00841747184093SterlingSLK G6L UXL22024-11-01
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00841747184116SterlingSLK G6L UL22024-11-01
00841747184123SterlingSLK G6L UM+22024-11-01

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