FDA.reportPublic FDA data

Belly Bandit

Primary DI
00191653900066
Brand
Belly Bandit
Company
The Ergo Baby Carrier Inc.
Model
90006
Catalog number
SILBRSTBUFF:O/S
Device description
Silicone Stretch Mark Therapy for Breasts
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191653900066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191653900066001916539000661916539000660191653900066

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
134831606
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191653900028Belly Bandit90002VCOOLHCPER2024-10-07
00191653900059Belly Bandit90005BFHCCPNK:O/S2025-01-10
00191653900080Belly Bandit90008GELPKUPSIE2024-10-23
00191653900097Belly Bandit90009CMPSCKCHC:12025-01-10
00191653900103Belly Bandit90010CMPSCKCHC:22025-01-10
00191653900110Belly Bandit90011CMPSCKHGY:12025-01-10
00191653900127Belly Bandit90012CMPSCKHGY:22025-01-10
00191653900134Belly Bandit90013CMPSCKBLK:12025-01-10
00191653900141Belly Bandit90014CMPSCKBLK:22025-01-10
00191653900165Belly Bandit90016CSECUNBLK:XS2025-01-10
00191653900172Belly Bandit90017CSECUNBLK:S2025-01-10
00191653900189Belly Bandit90018CSECUNBLK:M2025-01-10
00191653900196Belly Bandit90019CSECUNBLK:L2025-01-10
00191653900202Belly Bandit90020CSECUNBLK:XL2025-01-10
00191653900219Belly Bandit90021CSECUNBLK:XXL2025-01-10
00191653900226Belly Bandit90022CSECUNNUDE:XS2025-01-10
00191653900233Belly Bandit90023CSECUNNUDE:S2025-01-10
00191653900240Belly Bandit90024CSECUNNUDE:M2025-01-10
00191653900257Belly Bandit90025CSECUNNUDE:L2025-01-10
00191653900264Belly Bandit90026CSECUNNUDE:XL2025-01-10

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