FDA.reportPublic FDA data

Securi-T

Primary DI
10610075069665
Brand
Securi-T
Company
HOLLISTER INCORPORATED
Model
7305234
Catalog number
7305234
Device description
2-Pc Ostomy System
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

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
10610075069665PackageGS124In Commercial Distribution
00610075069668PrimaryGS10
20610075069662Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007506966510610075069665
00610075069668006100750696686100750696680610075069668
2061007506966220610075069662

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter70Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-4060cs@hollister.com

Regulatory Flags#

DUNS number
005527098
Device count
10
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
false
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
10610075097149Adapt780578052026-03-13
10610075097156Adapt780678062026-03-13
10610075097163Adapt781578152026-03-13
10610075099440CeraPlus19002C19002C2026-03-01
10610075099457CeraPlus19003C19003C2026-03-01
10610075099471CeraPlus19004C19004C2026-03-01
10610075099488CeraPlus19202C19202C2026-03-01
10610075099495CeraPlus19203C19203C2026-03-01
10610075099501CeraPlus19204C19204C2026-03-01
10610075099518CeraPlus89001C89001C2026-03-01
10610075099525CeraPlus89002C89002C2026-03-01
10610075099600CeraPlus89003C89003C2026-03-01
10610075099617CeraPlus89004C89004C2026-03-01
10610075099624CeraPlus89005C89005C2026-03-01
20610075091922VaPro72082720822026-01-30
20610075092585VaPro72102721022026-01-30
20610075092592VaPro72122721222026-01-30
20610075092608VaPro72142721422026-01-30
20610075092615VaPro72084720842026-01-30
20610075092622VaPro72104721042026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05701780415583SenSura MioColoplast A/SEXB2026-01-21
05701780416320SenSura MioColoplast A/SEXB2026-01-21
05701780418263SenSura MioColoplast A/SEXB2026-01-21
05701780419154SenSura MioColoplast A/SEXB2026-01-21
05701780420099SenSura MioColoplast A/SEXB2026-01-21
05701780421065SenSura MioColoplast A/SEXB2026-01-21
05701780357371SenSura MioColoplast A/SEXB2025-11-20
05701780357432SenSura MioColoplast A/SEXB2025-11-20
05701780357494SenSura MioColoplast A/SEXB2025-11-20
05701780357555SenSura MioColoplast A/SEXB2025-11-20
05701780357616SenSura MioColoplast A/SEXB2025-11-20
05701780357678SenSura MioColoplast A/SEXB2025-11-20
05701780357739SenSura MioColoplast A/SEXB2025-11-20
05701780358033SenSura MioColoplast A/SEXB2025-11-20
05701780358071SenSura MioColoplast A/SEXB2025-11-20
05701780358101SenSura MioColoplast A/SEXB2025-11-20
05701780358149SenSura MioColoplast A/SEXB2025-11-20
05701780358187SenSura MioColoplast A/SEXB2025-11-20
05701780358217SenSura MioColoplast A/SEXB2025-11-20
05701780359504SenSura MioColoplast A/SEXB2025-11-20
05701780359627SenSura MioColoplast A/SEXB2025-11-20
05701780359689SenSura MioColoplast A/SEXB2025-11-20
05701780356084SenSura MioColoplast A/SEXB2025-04-25
05701780356145SenSura MioColoplast A/SEXB2025-04-25
05701780356206SenSura MioColoplast A/SEXB2025-04-25
05701780356268SenSura MioColoplast A/SEXB2025-04-25
05701780356329SenSura MioColoplast A/SEXB2025-04-25
05701780359948SenSura MioColoplast A/SEXB2025-04-25
05701780360029SenSura MioColoplast A/SEXB2025-04-25
05701780360050SenSura MioColoplast A/SEXB2025-04-25