FDA.reportPublic FDA data

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Primary DI
20610075114058
Brand
New Image
Company
HOLLISTER INCORPORATED
Model
19006
Device description
Non-sterile Kit with Drainable Pouch, Lock 'n Roll Closure, Loop Ostomy Bridge
Published
2016-09-21
Public version status
Update
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
EZPRod, colostomy
PQEOstomy care kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZPRod, ColostomyGastroenterology, Urology2
PQEOstomy Care KitGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075114058PackageGS16In Commercial Distribution
00610075114054PrimaryGS10
00610075110469Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007511405820610075114058
00610075114054006100751140546100751140540610075114054
00610075110469006100751104696100751104690610075110469

GMDN Terms#

Term, Definition table
TermDefinition
Colostomy rodA device that is placed through a loop of colon brought out through the abdominal wall to temporarily keep it from sliping back through the surgical opening during the loop colostomy procedure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter89Millimeter
Lumen/Inner Diameter102Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610075040070InstaFlo330162016-09-21
00610075052332Apogee HC908102016-09-21
00610075052349Apogee HC910062016-09-21
00610075052356Apogee HC910102016-09-21
00610075052363Apogee HC912062016-09-21
00610075052370Apogee HC912162016-09-21
00610075052387Apogee HC914062016-09-21
00610075052394Apogee HC914162016-09-21
00610075052400Apogee HC916162016-09-21
00610075052417Apogee HC918162016-09-21
00610075052424Apogee HC912262016-09-21
00610075052431Apogee HC914262016-09-21
00610075052448Apogee HC916262016-09-21
10610075117250Premier89005890052022-12-01
10610075198631New Image19503195032022-12-01
00610075198443Adapt7730US2018-01-01
00610075198450Adapt7731US2018-01-01
00610075096152VaPro77124771242026-06-06
00610075096169VaPro77144771442026-06-06
00610075096176VaPro77164771642026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00661613006164Loop Ostomy RodMarlen Manufacturing And Development Co.EZP2026-05-03
00661613006171Loop Ostomy RodMarlen Manufacturing And Development Co.EZP2026-05-03
00661613006188Loop Ostomy RodMarlen Manufacturing And Development Co.EZP2026-05-03
00661613006195Loop Ostomy RodMarlen Manufacturing And Development Co.EZP2026-05-03
00661613006201Loop Ostomy RodMarlen Manufacturing And Development Co.EZP2026-05-03
00610075099443CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099450CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099474CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099481CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099498CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099504CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099511CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099528CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099603CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099610CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099627CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099440CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099457CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099471CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099488CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099495CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099501CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099518CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099525CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099600CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099617CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099624CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075098514New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098521New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098538New ImageHOLLISTER INCORPORATEDPQE2025-10-10