AccessGUDID - DEVICE: MEDPOR (07613252083993)

GUDID

Device Identifier (DI) Information

Brand Name: MEDPOR
Version or Model: 7544
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7544
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 07613252083993
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: Mandibular Angle Ramus W/Infer. Ridge ES-10 - Right

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
Mandibular condyle prosthesis	A sterile implantable device designed to replace the natural mandibular condylar head, providing an articulation with the mandibular fossa and a partial substitution of the temporomandibular joint articulation. It is typically made of a combination of a metal frame and plastic (e.g., polymethylmethacrylate) or a combination of metal and polymeric materials. The device is almost always used in combination with mandibular fossa components in total temporomandibular joint (TMJ) prostheses.

GMDN Preferred Term Name

GMDN Definition

Mandibular condyle prosthesis

A sterile implantable device designed to replace the natural mandibular condylar head, providing an articulation with the mandibular fossa and a partial substitution of the temporomandibular joint articulation. It is typically made of a combination of a metal frame and plastic (e.g., polymethylmethacrylate) or a combination of metal and polymeric materials. The device is almost always used in combination with mandibular fossa components in total temporomandibular joint (TMJ) prostheses.

FDA Product Code

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Product Code	Product Code Name
FWP	PROSTHESIS, CHIN, INTERNAL

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

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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: Thickness: 5.0 Millimeter
Height: 32.0 Millimeter
Device Size Text, specify: Thickness: 4.0 Millimeter
Length: 79.0 Millimeter
Device Size Text, specify: Thickness: 10.0 Millimeter
Width: 10.0 Millimeter

Device Record Status

Public Device Record Key: 4a9357d0-f52a-4114-8054-31e03476bf31
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2015