AccessGUDID - DEVICE: FEMORAL BRUSH (08031497002668)

GUDID

Device Identifier (DI) Information

Brand Name: FEMORAL BRUSH
Version or Model: SPZ-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TECRES SPA

Primary DI Number: 08031497002668
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 435428396 *Terms of Use

Device Description: FEMORAL BRUSH facilitates the removal of bone chips and tissue from the medullary canal. It is intended to be used for helping the surgeons, during the fixation of artificial joint prosthesis with the acrylic bone cement, in cleaning the femoral canal from debris after the canal has been drilled and before the cement application.

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:	Yes
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?
47690	Intramedullary canal cleaning brush, single-use	A sterile, hand-held, manual surgical instrument designed to remove blood clots and bone debris from the intramedullary canal of a bone (marrow space) in preparation for the insertion of orthopaedic cement. It typically consists of a handle at the proximal end and bristles or fibres at the distal end. The stiff bristles or fibres radiate out around a central shaft which may be flexible or rigid. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEC	Brush, Scrub, Operating-Room

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: 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: be9a9724-8c76-4dbf-827e-3d3691041d9d
Public Version Date: October 03, 2022
Public Version Number: 1
DI Record Publish Date: September 23, 2022