AccessGUDID - DEVICE: MEDPOR (07613252086277)

GUDID

Device Identifier (DI) Information

Brand Name: MEDPOR
Version or Model: 9554
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9554
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 07613252086277
Issuing Agency: GS1
Commercial Distribution End Date: March 03, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: Nasal Shell Implant - Large with Sizing Template

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31038	Nasal cartilage support implant, non-bioabsorbable	A non-bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose, by providing structural support to the cartilage. It is a shaped device made of synthetic polymer materials (e.g., solid silicone rubber).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FWP	PROSTHESIS, CHIN, INTERNAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922489	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 20.0 Millimeter
Height: 18.0 Millimeter
Length: 40.0 Millimeter

Device Record Status

Public Device Record Key: 697cd7f7-709f-4c24-98b5-8c17f64d73af
Public Version Date: March 17, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2015