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Primary DI
20610075181531
Brand
New Image
Company
HOLLISTER INCORPORATED
Model
18153
Catalog number
18153
Device description
2-Piece Ostomy Irrigator Sleeve
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EXDIrrigator, ostomy

Product Code Classifications

CodeDeviceSpecialtyClass
EXDIrrigator, OstomyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20610075181531PackageGS124In Commercial Distribution
00610075181537PrimaryGS10
00610075083787Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007518153120610075181531
00610075181537006100751815376100751815370610075181537
00610075083787006100750837876100750837870610075083787

GMDN Terms

TermDefinition
Colostomy irrigation kit, single-useA collection of non-sterile devices designed to wash out the colon through a colostomy site. It typically includes a container of fluid, tubing with a cone-shaped tip, or a soft and flexible catheter with a retention shield. This is a single-use device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter57Millimeter

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
005527098
Device count
5
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
true
Sterilization required before use
false

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