FDA.reportPublic FDA data

Coloplast

Primary DI
05708932556569
Brand
Coloplast
Company
Coloplast A/S
Model
95050
Catalog number
95050
Published
2024-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOKSCISSORS, MEDICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOKScissors, Medical, DisposableGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932556576PackageGS112In Commercial Distribution
05708932556583PackageGS130In Commercial Distribution
05708932556569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932556576057089325565765708932556576
05708932556583057089325565835708932556583
05708932556569057089325565695708932556569

GMDN Terms#

Term, Definition table
TermDefinition
Ostomy appliance scissorsA hand-held manual device designed to be used by a patient (layperson) in the home to cut an ostomy appliance (e.g., ostomy flange); it is not intended to cut tissues, sutures, or bandages. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is typically made of metal and is available in various designs and sizes (e.g., straight or curved blades). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.

Contacts#

Phone, Email table
PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05701780385411SenSura Mio Convex18541185412026-06-08
05701780385442SenSura Mio Convex18542185422026-06-08
05701780385473SenSura Mio Convex18543185432026-06-08
05701780385503SenSura Mio Convex18544185442026-06-08
05701780385541SenSura Mio Convex18545185452026-06-08
05701780385572SenSura Mio Convex18546185462026-06-08
05701780385602SenSura Mio Convex18547185472026-06-08
05701780385633SenSura Mio Convex18548185482026-06-08
05701780385664SenSura Mio Convex18549185492026-06-08
05701780385701SenSura Mio Convex18550185502026-06-08
05701780385732SenSura Mio Convex18551185512026-06-08
05701780385763SenSura Mio Convex18540185402026-06-08
05708932487047Peristeen29125291252016-09-20
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8142205SFPP2Garish ApparelsGARISH APPARELSJOK2026-06-06
G8142385SFPP2Garish ApparelsGARISH APPARELSJOK2026-06-06
04059453062727Hermann Medizintechnik GmbHHermann Medizintechnik GmbHJOK2026-02-24
04059453062765Hermann Medizintechnik GmbHHermann Medizintechnik GmbHJOK2025-09-09
00653160385397MEDLINEMEDLINE INDUSTRIES, INC.JOK2025-02-21
10653160385547MEDLINEMEDLINE INDUSTRIES, INC.JOK2025-02-11
10653160386155MEDLINEMEDLINE INDUSTRIES, INC.JOK2025-02-11
00653160385540MEDLINEMEDLINE INDUSTRIES, INC.JOK2025-02-11
00653160386158MEDLINEMEDLINE INDUSTRIES, INC.JOK2025-02-11
20197344102584MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102591MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102607MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102621MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102638MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102645MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344117984MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102581MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102598MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102604MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102628MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102635MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102642MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344117981MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102614MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-25
30197344102611MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-25
05708932556576ColoplastColoplast A/SJOK2024-08-23
00193489139870CURADMEDLINE INDUSTRIES, INC.JOK2024-08-22
10193489139877CURADMEDLINE INDUSTRIES, INC.JOK2024-08-22
10195327656249Medline Industries, Inc.MEDLINE INDUSTRIES, INC.JOK2024-07-29
40195327656240Medline Industries, Inc.MEDLINE INDUSTRIES, INC.JOK2024-07-29