FDA.reportPublic FDA data

Oleeva Foam 5x5

Primary DI
00810050460170
Brand
Oleeva Foam 5x5
Company
Bio Med Sciences, Inc.
Model
3225
Catalog number
3225
Device description
Silicone Gel Sheeting bonded with Foam
Published
2023-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDAElastomer, Silicone, For Scar Management

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDAElastomer, Silicone, For Scar ManagementGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002109000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002109000OLEEVA FOAMBio Med Sciences, Inc.2000-08-31MDA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810050460177PackageGS110In Commercial Distribution
00810050460170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005046017710810050460177
00810050460170008100504601708100504601700810050460170

GMDN Terms#

Term, Definition table
TermDefinition
Scar-management dressing, reusableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch
Length13Centimeter
Width5Inch
Width13Centimeter

Contacts#

Phone, Email table
PhoneEmail
+1 (610) 530-3193BioMedCS@silon.com

Regulatory Flags#

DUNS number
364435974
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050460163Oleeva Foam 1.5x5320832082023-12-31
00810050460187Oleeva Foam 5x10325032502023-12-31
00810050460194Oleeva Foam 11x12329632962023-12-31
00810050460200Oleeva Foam Abdominoplasty Shape32APS32APS2023-12-31
00810050460217Oleeva Foam Breast Areola Shape32BA32BA2023-12-31
00810050460224Oleeva Foam 5.2x2.232BF32BF2023-12-31
00810050460231Oleeva Foam Breast Anchor Shape32BFS32BFS2023-12-31
00810050460248Oleeva Foam Breast Kit32BKS32BKS2023-12-31
00810050460255Oleeva Foam C-Section32CS32CS2023-12-31
00810050460262Oleeva Foam Vertical Mastopexy Shape32VM32VM2023-12-31
00810050460279Oleeva Clear 1.5x3350435042023-12-31
00810050460286Oleeva Clear 1.5x5350835082023-12-31
00810050460293Oleeva Clear 5x5352535252023-12-31
00810050460309Oleeva Clear 5x10355035502023-12-31
00810050460316Oleeva Clear 8x12359635962023-12-31
00810050460323Oleeva Fabric 1.5x3370437042023-12-31
00810050460378Oleeva Fabric 1.5x5370837082023-12-31
00810050460385Oleeva Fabric 1.5x7371037102023-12-31
00810050460392Oleeva Fabric 2x8371637162023-12-31
00810050460408Oleeva Fabric 5x5372537252023-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05000223482589CICA CARESMITH & NEPHEW MEDICAL LIMITEDMDA2026-04-30
05000223502157CICA CARESMITH & NEPHEW MEDICAL LIMITEDMDA2026-04-30
00860015727305KegelStar Port IncMDA2026-04-25
00885914040461RolyanPerformance Health Supply, LLCMDA2026-03-20
00885914040478RolyanPerformance Health Supply, LLCMDA2026-03-20
00885914040485RolyanPerformance Health Supply, LLCMDA2026-03-20
00358962230806ScarAway Silicone Scar TapeAlliance Pharma Inc.MDA2026-02-19
00850072068770CeladiaBiowound Solutions, Inc.MDA2025-12-18
00850072068787CeladiaBiowound Solutions, Inc.MDA2025-12-18
10850072068777CeladiaBiowound Solutions, Inc.MDA2025-12-18
10850072068784CeladiaBiowound Solutions, Inc.MDA2025-12-18
04719884330269H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-12
04719884330368H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-12
04719884333765H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-11
06972949026110SensifineHangzhou R&L Medical Device Co., LtdMDA2025-12-08
16972949026117SensifineHangzhou R&L Medical Device Co., LtdMDA2025-12-08
00816465020008NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020015NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020046NewGel+UV Silicone Gel for Scars + SPF30Newmedical Technology, Inc.MDA2025-08-07
00816465020213Silagen 100% Pure Silicone GelNewmedical Technology, Inc.MDA2025-08-07
00816465020220Silagen 100% Pure Silicone GelNewmedical Technology, Inc.MDA2025-08-07
00816465020237Silagen Silicone Gel for Scars + SPF30 UV ProtectionNewmedical Technology, Inc.MDA2025-08-07
00816465020244Silagen Silicone Gel for Scars + SPF30 UV ProtectionNewmedical Technology, Inc.MDA2025-08-07
00816465020299NewGel+E Advanced Silicone Gel for ScarsNewmedical Technology, Inc.MDA2025-08-07
00816465020305NewGel+E Advanced Silicone Gel for ScarsNewmedical Technology, Inc.MDA2025-08-07
00816465020329NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020336NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020343NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020350NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020367Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07