AccessGUDID - DEVICE: Bone Plug (07613327036671)

GUDID

Device Identifier (DI) Information

Brand Name: Bone Plug
Version or Model: 6215-5-011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6215-5-011
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327036671
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: Canal -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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile	A sterile, 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 is not intended for spinal indication.

GMDN Preferred Term Name

GMDN Definition

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

A sterile, 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 is not intended for spinal indication.

FDA Product Code

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Product Code	Product Code Name
LZN	CEMENT OBTURATOR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K951860	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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Size: MED
Device Size Text, specify: Diameter: 25.0 Millimeter

Device Record Status

Public Device Record Key: e1e2f751-1c1b-463d-bb4e-2eca80a7423d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015