AccessGUDID - DEVICE: Centralizer (07613327035810)

GUDID

Device Identifier (DI) Information

Brand Name: Centralizer
Version or Model: 6259-8-150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6259-8-150
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327035810
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: Distal Stem Centralizer-Cemented

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
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
MAY	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
KWL	Prosthesis, hip, hemi-, femoral, metal
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
JDG	Prosthesis, hip, femoral component, cemented, metal
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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
Device Size Text, specify: Diameter: 15.0 Millimeter

Device Record Status

Public Device Record Key: 07c592c7-1dea-488a-9097-57d8a4380643
Public Version Date: February 03, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2015