FDA.reportPublic FDA data

OSTUPMED

Primary DI
16970944382931
Brand
OSTUPMED
Company
Jiangsu Ostup Medical Products Co., Ltd.
Model
250
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EXBCollector, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXBCollector, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970944382931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697094438293116970944382931

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal ostomy base plate, flatA non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. It is typically self-applied by the patient. This is a single-use device.

Regulatory Flags#

DUNS number
543933888
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970944382415OSTUPMED11012026-10-27
06970944383740OSTUPMED40012026-10-27
06970944383757OSTUPMED40022026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00618029980274Stryker Fecal Management SystemSAGE PRODUCTS, LLCEXB2023-03-07
00610075029839New ImageHOLLISTER INCORPORATEDEXB2022-12-01
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00610075029853New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029860New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029877New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029884New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029891New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029907New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029914New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029921New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075031849HollisterHOLLISTER INCORPORATEDEXB2022-12-01
00610075031863HollisterHOLLISTER INCORPORATEDEXB2022-12-01
00610075033263Karaya 5HOLLISTER INCORPORATEDEXB2022-12-01
00610075037742PouchkinsHOLLISTER INCORPORATEDEXB2022-12-01
00610075051762New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051779New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051786New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051793New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051809New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051816New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051823New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051830New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051847New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051854New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051861New ImageHOLLISTER INCORPORATEDEXB2022-12-01
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00610075051991New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075052004New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075052011New ImageHOLLISTER INCORPORATEDEXB2022-12-01