FDA.report

Securi-T

Primary DI
10610075069474
Brand
Securi-T
Company
HOLLISTER INCORPORATED
Model
7126049
Catalog number
7126049
Device description
Adjustable Ostomy Belt
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
false

Related Records

Contact Domains

Product Codes

CodeName
EXBCOLLECTOR, OSTOMY

Product Code Classifications

CodeDeviceSpecialtyClass
EXBCollector, OstomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10610075069474PackageGS1140In Commercial Distribution
00610075069477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007506947410610075069474
00610075069477006100750694776100750694770610075069477

GMDN Terms

TermDefinition
Intestinal stoma shield/support belt, reusableA non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. Also known as a stoma protector it is usually attached by the patient to the base plate/wafer that retains the stomal bag, or might be placed directly over the stomal opening when the bag is removed; it may in addition include an attachable ostomy bag protector. This is a reusable device.

Device Sizes

TypeValueUnit
Length66Centimeter
Length109Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)323-4060cs@hollister.com

Regulatory Flags

DUNS number
005527098
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
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

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