AccessGUDID - DEVICE: EXETER (04546540167460)

GUDID

Device Identifier (DI) Information

Brand Name: EXETER
Version or Model: 0942-2-120
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0942-2-120
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 04546540167460
Issuing Agency: GS1
Commercial Distribution End Date: November 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: BONE PLUG

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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
LZN	CEMENT OBTURATOR

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: 20.0 Millimeter

Device Record Status

Public Device Record Key: 3229e863-4ec0-426d-b1a8-33ff93e4063a
Public Version Date: February 03, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2015