AccessGUDID - DEVICE: Symbionic Leg (05690967600679)

GUDID

Device Identifier (DI) Information

Brand Name: Symbionic Leg
Version or Model: SBL13210
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SBL13210
Company Name: OSSUR AMERICAS, INC.

Primary DI Number: 05690967600679
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: SYMBIONIC LEG 3 TRIAL 25-30

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?
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
41541	Knee-disarticulation prosthesis	An artificial substitute for a disarticulation amputation at the knee joint, or used in cases of limb deficiency at birth, 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 typically made of metal and plastic and is typically constructed as a polycentric hinge that incorporates an upper joint section that fits against a full-length prosthetic femur. It is typically spring-assisted to control the swing of the leg.	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
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage 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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2394ebde-f557-4614-8e87-cae3c357175b
Public Version Date: January 31, 2020
Public Version Number: 2
DI Record Publish Date: May 16, 2018