AccessGUDID - DEVICE: Oleeva Foam Breast Areola Shape (00810050460217)

GUDID

Device Identifier (DI) Information

Brand Name: Oleeva Foam Breast Areola Shape
Version or Model: 32BA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 32BA
Company Name: Bio Med Sciences, Inc.

Primary DI Number: 00810050460217
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364435974 *Terms of Use

Device Description: Silicone Gel Sheeting bonded with Foam

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
44898	Scar-management dressing, reusable	A covering made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDA	Elastomer, silicone, for scar management

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002109	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
Outer Diameter: 2.5 Inch
Outer Diameter: 6 Centimeter

Device Record Status

Public Device Record Key: c0981bf4-c968-4069-8633-ebfebcbcdc12
Public Version Date: February 16, 2024
Public Version Number: 2
DI Record Publish Date: December 31, 2023