FDA.reportPublic FDA data

Hollister

Primary DI
00610075077670
Brand
Hollister
Company
HOLLISTER INCORPORATED
Model
7767
Device description
Loop Ostomy Bridge - Sterile
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZPRod, colostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZPRod, ColostomyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075077674PackageGS124In Commercial Distribution
00610075077670PrimaryGS10
00610075088331Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007507767420610075077674
00610075077670006100750776706100750776700610075077670
00610075088331006100750883316100750883310610075088331

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.

Regulatory Flags#

DUNS number
005527098
Device count
20
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610075031849Hollister318431842022-12-01
00610075031863Hollister318631862022-12-01
00610075077601Adapt776077602022-12-01
00610075179626ActiFlo320042016-09-21
00610075179633ActiFlo320052016-09-21
00610075179640ActiFlo320062016-09-21
00610075179657ActiFlo320072016-09-21
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

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
00860002701325Barbell Loop Ostomy DeviceTOOLS FOR SURGERY, LLCEZP2023-07-17
00860002701349Barbell Loop Ostomy DeviceTOOLS FOR SURGERY, LLCEZP2023-07-17
00860002701356Barbell Loop Ostomy DeviceTOOLS FOR SURGERY, LLCEZP2023-07-17
05708932752558ColoplastColoplast A/SEZP2022-12-26
00768455116003NATURACONVATEC, PURCHASING DEPARTMENTEZP2022-09-28
10768455116000NATURACONVATEC, PURCHASING DEPARTMENTEZP2022-09-28
00768455116010SUR-FIT NATURACONVATEC, PURCHASING DEPARTMENTEZP2019-03-22
10768455116017SUR-FIT NATURACONVATEC, PURCHASING DEPARTMENTEZP2019-03-22
20610075077674HollisterHOLLISTER INCORPORATEDEZP2016-09-21
20610075114058New ImageHOLLISTER INCORPORATEDEZP2016-09-21
20610075114089New ImageHOLLISTER INCORPORATEDEZP2016-09-21
20610075114119New ImageHOLLISTER INCORPORATEDEZP2016-09-21
20610075114140New ImageHOLLISTER INCORPORATEDEZP2016-09-21
00768455115501SUR-FIT LOOP OSTOMY ROD 65MMCONVATEC, PURCHASING DEPARTMENTEZP2016-09-01
10768455115508SUR-FIT LOOP OSTOMY ROD 65MMCONVATEC, PURCHASING DEPARTMENTEZP2016-09-01
00768455115518SUR-FIT LOOP OSTOMY ROD 90MMCONVATEC, PURCHASING DEPARTMENTEZP2016-09-01
00768455115983SUR-FIT NATURACONVATEC, PURCHASING DEPARTMENTEZP2016-09-01
00768455115990SUR-FIT NATURACONVATEC, PURCHASING DEPARTMENTEZP2016-09-01