AccessGUDID - DEVICE: MEDPOR (07613252085041)

GUDID

Device Identifier (DI) Information

Brand Name: MEDPOR
Version or Model: 8330
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8330
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 07613252085041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: Ear Base Extended - 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
Ear prosthesis	A sterile device intended to be implanted to reconstruct the external ear by replacing damaged or missing tissue. It is typically made of a polymer material (e.g., solid silicone rubber).

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
Width: 30.0 Millimeter
Length: 59.0 Millimeter

Device Record Status

Public Device Record Key: e7bc8163-617c-4615-abcc-445b1798bbcc
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2015