AccessGUDID - DEVICE: Espire Elbow Pro (00841747182006)

GUDID

Device Identifier (DI) Information

Brand Name: Espire Elbow Pro
Version or Model: EEP LWS CO
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: COLLEGE PARK INDUSTRIES, INC.

Primary DI Number: 00841747182006
Issuing Agency: GS1
Commercial Distribution End Date: July 13, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 623191137 *Terms of Use

Device Description: Espire Elbow Pro, Left, White, Small, COAPT

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41100	Myoelectric elbow prosthesis	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb1a7a4a-a2ee-4a3a-8055-016eae77eaad
Public Version Date: July 14, 2021
Public Version Number: 2
DI Record Publish Date: July 16, 2020