AccessGUDID - DEVICE: ESPIRE (05056394328294)

GUDID

Device Identifier (DI) Information

Brand Name: ESPIRE
Version or Model: Espire Elbow Pro- Right- Black Carbon Finish- Standard
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EEP-R001D
Company Name: HUGH STEEPER LIMITED

Primary DI Number: 05056394328294
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 210280350 *Terms of Use

Device Description: No description.

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?
41099	Electrical elbow prosthesis	An 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. The control of the device is achieved by an electromechanical switch for the motor that is operated by body movement using straps or cables.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRE	Joint, Elbow, External Limb Component, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182757	000

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: b9293e9b-5a16-4d91-8476-ea7c2cd95e71
Public Version Date: July 10, 2023
Public Version Number: 1
DI Record Publish Date: June 30, 2023