AccessGUDID - DEVICE: Cement Restrictor (08031497001418)

GUDID

Device Identifier (DI) Information

Brand Name: Cement Restrictor
Version or Model: TPA-24
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TECRES SPA

Primary DI Number: 08031497001418
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 435428396 *Terms of Use

Device Description: Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device. Cement Restrictor is provided with the related inserter.

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:	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?
38799	Polymer orthopaedic cement restrictor, non-bioabsorbable	A non-bioabsorbable, implantable device designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is typically made of polyetheretherketone (PEEK) or ultrahigh molecular weight polyethylene (UHMWPE) and is available in a variety of designs (e.g., straight or tapered, hollow with a fenestrated surface), and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and it is not intended for spinal application.	Active	true

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
Outer Diameter: 24 Millimeter

Device Record Status

Public Device Record Key: 2bc34f33-b31d-485a-83f9-393d0bf8b76f
Public Version Date: February 03, 2023
Public Version Number: 4
DI Record Publish Date: October 12, 2015