AccessGUDID - DEVICE: Cemex Prep Kit (28031497000323)

GUDID

Device Identifier (DI) Information

Brand Name: Cemex Prep Kit
Version or Model: KIT-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TECRES SPA

Primary DI Number: 28031497000323
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 435428396 *Terms of Use

Device Description: Cemex Prep kit is intended to be used for helping the surgeons during the fixation of artificial joint prostheses with the acrylic bone cement. The device contains a number of accessories useful during a prosthesis implantation surgery performed using the cementing technique. The components are packaged all together in a unique sterile package single-use.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
45253	Orthopaedic cement preparation/delivery kit	A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDK	Prosthesis, Hip, Cement Restrictor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021765	000

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: f8505452-a5b3-4f88-b2a8-5e33e9a512f5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 08, 2015