AccessGUDID - DEVICE: Spectrum Designs Medical (B018550611LT1)

GUDID

Device Identifier (DI) Information

Brand Name: Spectrum Designs Medical
Version or Model: Pectoral 4, Aiache, Left, Size 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 550-611LT
Company Name: SPECTRUM DESIGNS INC

Primary DI Number: B018550611LT1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148681521 *Terms of Use

Device Description: No description.

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?
48163	Pectoral implant	An implantable device designed for cosmetic augmentation (submuscular implantation) or reconstruction (e.g., to correct injuries/congenital absence) of the pectoral muscle(s). It is a preshaped (e.g., convex/concave oval-shaped) device typically composed of silicone elastomer.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIC	Implant, Muscle, Pectoralis

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: 476c112e-98fb-4c81-8619-e60b5ef70a95
Public Version Date: February 03, 2023
Public Version Number: 4
DI Record Publish Date: October 23, 2015