AccessGUDID - DEVICE: Spectrum Designs Medical (B018250314S1)

GUDID

Device Identifier (DI) Information

Brand Name: Spectrum Designs Medical
Version or Model: Curvilinear Chin, size 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 250-314S
Company Name: SPECTRUM DESIGNS INC

Primary DI Number: B018250314S1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148681521 *Terms of Use

Device Description: Allergan Distributed

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?
35261	Chin prosthesis	A sterile device implanted in the soft tissue of the chin to correct chin deformities or improve facial appearance. It is usually made of a polymer material.	Active	true

FDA Product Code

[?]

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
No Device Sizes

Device Record Status

Public Device Record Key: 8e2024f0-4cf9-4f0b-b108-24e0ec4468f1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 31, 2016