AccessGUDID - DEVICE: Osseointegration Prosthetic Limb (19356371001053)

GUDID

Device Identifier (DI) Information

Brand Name: Osseointegration Prosthetic Limb
Version or Model: 0 Degree Bushing
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OPL-LLC-B
Company Name: OSSEOINTEGRATION INTERNATIONAL PTY LTD

Primary DI Number: 19356371001053
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 743779676 *Terms of Use

Device Description: LLC Bushing

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
61229	External lower-limb prosthesis structural/alignment component	A component of an external lower limb prosthesis [hip, knee, or ankle-foot prosthesis] designed as: 1) a structural element to connect and maintain the structural integrity between the components of the prosthesis [e.g., between a socket and a knee joint prosthesis]; and/or 2) an alignment element to enable adjustment of the orientation of the prosthesis components relative to each other and to the patient (e.g., mediolateral shift, anteroposterior tilt). It may be in the form of a tube, pylon, adaptor, attachment block, clamp, pyramid, socket anchor, plate, or other design, and is intended to remain an integral part of the fitted prosthesis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQO	Device, Prosthesis Alignment

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: c32fc419-0014-4a89-9ff0-c93850036d1a
Public Version Date: December 26, 2022
Public Version Number: 1
DI Record Publish Date: December 16, 2022