AccessGUDID - DEVICE: Symbionic Leg (05690977432857)

GUDID

Device Identifier (DI) Information

Brand Name: Symbionic Leg
Version or Model: SMBU5243
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SMBU5243
Company Name: OSSUR AMERICAS, INC.

Primary DI Number: 05690977432857
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 139280028 *Terms of Use

Device Description: KIT SYMBIONIC 3 UNITY C5S243Y

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):	Yes
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?
64721	Mechatronic external knee prosthesis	A battery-powered electromechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for motion control is based on hydraulic, pneumatic, or magnetorheological actuation regulated by a motion-feedback mechanism using electronic sensors and software. It is intended to respond to changes in motion in real-time by continuously sensing knee flexion speed and temperature and instantly adjusting motion resistance within a single step. Known as a microprocessor-controlled knee (MPK), it may have various designs and functional features for support during a variety of activities.	Active	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
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 45 Degrees Celsius
Handling Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3124cbe2-8e89-40a8-bb6a-1c5d8483c9eb
Public Version Date: March 09, 2021
Public Version Number: 2
DI Record Publish Date: May 16, 2018