FDA.reportPublic FDA data

SUR-FIT LOOP OSTOMY ROD 65MM

Primary DI
10768455115508
Brand
SUR-FIT LOOP OSTOMY ROD 65MM
Company
CONVATEC, PURCHASING DEPARTMENT
Model
022355
Catalog number
22355
Device description
SUR-FIT LOOP OSTOMY ROD 65MM
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
10768455115508PackageGS112In Commercial Distribution
00768455115501PrimaryGS10
00768455179015Unit of UseGS10
08768455115503Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845511550810768455115508
00768455115501007684551155017684551155010768455115501
00768455179015007684551790157684551790150768455179015
08768455115503087684551155038768455115503

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.5Inch
Length6.5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
809784593
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768455145836FLEXI-SEAL4217032019-11-18
00768455157150FLEXI-SEAL4223032019-11-18
00768455185924FLEXI-SEAL4111082022-09-09
00768455209620FLEXI-SEAL4238542023-08-16
30768455143017FLEXI-SEAL4216304216302017-04-26
00768455108565FLEXI-SEAL4111004111002016-09-01
00768455109852FLEXI-SEAL4111004111002016-09-01
00768455117178FLEXI-SEAL4180002016-09-01
00768455143016FLEXI-SEAL4216302017-05-12
00768455201303AVELLE4466504466502023-02-22
00768455108268STOMAHESIVE0255102022-09-28
00768455101399ACTIVELIFE0209222018-11-09
00768455101405ACTIVELIFE0227502018-11-09
00768455101412ACTIVELIFE0227512018-11-09
00768455101429ACTIVELIFE0227522018-11-09
00768455101436ACTIVELIFE0227532018-11-09
00768455101443ACTIVELIFE227542018-11-09
00768455101450ACTIVELIFE0227552018-11-09
00768455101467ACTIVELIFE0227562018-11-09
00768455101474ACTIVELIFE0227572018-11-09

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
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
00768455115518SUR-FIT LOOP OSTOMY ROD 90MMCONVATEC, PURCHASING DEPARTMENTEZP2016-09-01
00768455115983SUR-FIT NATURACONVATEC, PURCHASING DEPARTMENTEZP2016-09-01
00768455115990SUR-FIT NATURACONVATEC, PURCHASING DEPARTMENTEZP2016-09-01