AccessGUDID - DEVICE: MEDPOR (07613252084822)

GUDID

Device Identifier (DI) Information

Brand Name: MEDPOR
Version or Model: 83004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 83004
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 07613252084822
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: Midface Rim-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
Malar prosthesis	An implantable device designed to augment or maintain the soft-tissue anatomy of the malar area (cheek). The device is typically a solid elastomer (e.g., silicone) available in several shapes and sizes for subdermal implantation in the malar area for cosmetic or reconstructive purposes following traumatic or disease/congenital deformation. This is a single-use device.

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Thickness: 3.0 Millimeter
Width: 28.0 Millimeter
Length: 47.0 Millimeter

Device Record Status

Public Device Record Key: b9494a2a-dfa2-4516-884e-08daf5df3c44
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2015