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Primary DI
20610075118285
Brand
New Image
Company
HOLLISTER INCORPORATED
Model
14902
Catalog number
14902
Device description
2-Piece Ostomy Skin Barrier, Convex, Flextend
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
20610075118285PackageGS124In Commercial Distribution
00610075118281PrimaryGS10
00610075073535Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007511828520610075118285
00610075118281006100751182816100751182810610075118281
00610075073535006100750735356100750735350610075073535

GMDN Terms

TermDefinition
Intestinal ostomy base plate, convexA non-sterile device designed with a convex surface intended to be applied and adhered to peristomal skin to facilitate 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. The convexity of the device is used to improve peristomal skin contact of a flush stoma or more typically a recessed stoma. It is typically self-applied by the patient. This is a single-use device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter19Millimeter
Lumen/Inner Diameter44Millimeter

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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