Oleeva Foam Breast Areola Shape

Basic Information

• Brand Name: Oleeva Foam Breast Areola Shape
• Primary DI: 00810050460217
• Version / Model: 32BA
• Catalog Number: 32BA
• Company Name: Bio Med Sciences, Inc.
• Labeler DUNS: 364435974
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-31
• Public Version: 2
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: c0981bf4-c968-4069-8633-ebfebcbcdc12

Device Description

Silicone Gel Sheeting bonded with Foam

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDA	Elastomer, silicone, for scar management	General, Plastic Surgery	878.4025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810050460214	GS1	Box	10	In Commercial Distribution
Primary	00810050460217	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K002109	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	2.5	Inch
Outer Diameter	6	Centimeter