FDA.reportPublic FDA data

OstomyGel

Primary DI
07898616351431
Brand
OstomyGel
Company
DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA
Model
290010003
Catalog number
290010003
Device description
Ostomy accessory
Published
2025-04-28
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
GDSBag, Stomal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDSBag, StomalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898616351431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898616351431078986163514317898616351431

GMDN Terms#

Term, Definition table
TermDefinition
Ostomy odour-absorbent/deodorizerA device used by an ostomate to absorb unwanted odours and/or emit fragrance to conceal any unpleasant odours emanating from their stoma/ostomy devices. It is available in various forms, such as a powder with anti-odour properties (e.g., Zeolite) or a portable spray, for convenient daily use. After application this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
904563269
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
07898616351141Therapy US (FDA)9800300359800300352025-12-17
07898616351400e-light I-US2300201482300201482025-03-05
07898616351417e-light B-US2300201492300201492025-03-05
07898616351424e-light V-US 2300201502300201502025-03-05
07898616351127Therapy EC (FDA)9800300329800300322025-01-21
07898616351134Therapy XT (FDA)2300200942300200942025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885632431173HalyardO&M HALYARD, INC.GDS2024-11-12
10885632431180HalyardO&M HALYARD, INC.GDS2024-11-12
10885632431197HalyardO&M HALYARD, INC.GDS2024-11-12
20885632431170HalyardO&M HALYARD, INC.GDS2024-11-12
20885632431187HalyardO&M HALYARD, INC.GDS2024-11-12
20885632431194HalyardO&M HALYARD, INC.GDS2024-11-12
00610075097722HollisterHOLLISTER INCORPORATEDGDS2023-04-07
00610075097753HollisterHOLLISTER INCORPORATEDGDS2023-04-07
00610075097777HollisterHOLLISTER INCORPORATEDGDS2023-04-07
20610075097726HollisterHOLLISTER INCORPORATEDGDS2023-04-07
20610075097757HollisterHOLLISTER INCORPORATEDGDS2023-04-07
20610075097771HollisterHOLLISTER INCORPORATEDGDS2023-04-07
00618029980274Stryker Fecal Management SystemSAGE PRODUCTS, LLCGDS2023-03-07
50618029980279Stryker Fecal Management SystemSAGE PRODUCTS, LLCGDS2023-03-07
10610075097729HollisterHOLLISTER INCORPORATEDGDS2022-12-01
10610075097750HollisterHOLLISTER INCORPORATEDGDS2022-12-01
10610075097774HollisterHOLLISTER INCORPORATEDGDS2022-12-01
20610075049367HollisterHOLLISTER INCORPORATEDGDS2022-12-01
20610075049459HollisterHOLLISTER INCORPORATEDGDS2022-12-01
20610075049497HollisterHOLLISTER INCORPORATEDGDS2022-12-01
00610075097739HollisterHOLLISTER INCORPORATEDGDS2022-09-21
00610075097760HollisterHOLLISTER INCORPORATEDGDS2022-09-21
00610075097784HollisterHOLLISTER INCORPORATEDGDS2022-09-21
20610075097733HollisterHOLLISTER INCORPORATEDGDS2022-09-21
20610075097764HollisterHOLLISTER INCORPORATEDGDS2022-09-21
20610075097788HollisterHOLLISTER INCORPORATEDGDS2022-09-21