FDA.reportPublic FDA data

Loop Ostomy Rod

Primary DI
00661613006201
Brand
Loop Ostomy Rod
Company
Marlen Manufacturing And Development Co.
Model
620
Device description
4in long with eyelet at one end and T-Bar at other end
Published
2026-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00661613006201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00661613006201006616130062016616130062010661613006201

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
004220711
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00661613006164Loop Ostomy Rod6162026-05-03
00661613006171Loop Ostomy Rod6172026-05-03
00661613006188Loop Ostomy Rod6182026-05-03
00661613006195Loop Ostomy Rod6192026-05-03
00661613318038Biliary Drainage Kit318032026-05-03
10661613525006UltraMax525002026-04-28

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
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
00610075077670HollisterHOLLISTER INCORPORATEDEZP2016-09-21
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