AccessGUDID - DEVICE: STRIDE Unicondylar Knee (00841153100366)

GUDID

Device Identifier (DI) Information

Brand Name: STRIDE Unicondylar Knee
Version or Model: 110059
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BLUE BELT TECHNOLOGIES, INC.

Primary DI Number: 00841153100366
Issuing Agency: GS1
Commercial Distribution End Date: December 16, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 015299627 *Terms of Use

Device Description: STRIDE Tibial Insert Implant SIZE E, 8 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
48070	Unicondylar knee insert	A sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: a4409884-d85b-41c8-ae8d-7d2f64cba564
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2015