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Primary DI
20610075110753
Brand
New Image
Company
HOLLISTER INCORPORATED
Model
18732
Catalog number
18732
Device description
2-Piece Closed Ostomy Pouch
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

Related Records

Contact Domains

Product Codes

CodeName
EXBCOLLECTOR, OSTOMY

Product Code Classifications

CodeDeviceSpecialtyClass
EXBCollector, OstomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20610075110753PackageGS112In Commercial Distribution
00610075110759PrimaryGS10
30610075110750Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007511075320610075110753
00610075110759006100751107596100751107590610075110759
3061007511075030610075110750

GMDN Terms

TermDefinition
Multiple-piece intestinal ostomy bag, closed-endedA plastic pouch designed to be attached around a faecal stoma for use as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The base plate remains attached around the stoma, typically for 2 to 3 days, when the pouch is removed and replaced. This is a single-use device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter44Millimeter

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
005527098
Device count
60
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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