AccessGUDID - DEVICE: Empower (04032767839360)

GUDID

Device Identifier (DI) Information

Brand Name: Empower
Version or Model: 1A1-1=L27-7/7-4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OTTO BOCK HEALTHCARE

Primary DI Number: 04032767839360
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 932133408 *Terms of Use
Previous DI: B155EM0B0

Device Description: 1A1-1 Empower, L, black, beige

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?
43569	Dynamic-response foot prosthesis	An artificial substitute for a foot designed as a component of an external lower-limb prosthesis to restore some of the appearance and/or function of the normal anatomy. It is available in a variety of designs (e.g., it may resemble the form of a natural foot, or have a split-toe design) and its construction is intended to enable the store and release of energy during the walking cycle to provide a sense of push-off and a more normal gait range. A dynamic-response foot is typically intended for an active and responsive patient to help increase activity level (e.g., vary walking speed, change direction quickly, walk long distances).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ISW	Assembly, Knee/Shank/Ankle/Foot, External

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: a9b94227-59df-4aab-a0a4-59126b475c91
Public Version Date: May 14, 2018
Public Version Number: 1
DI Record Publish Date: April 11, 2018