FDA.reportPublic FDA data

Coloplast

Primary DI
05708932556576
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
Rx
false
OTC
true
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
305524696
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05701780437066SenSura Mio Convex1373201373202026-04-30
05701780437127SenSura Mio Convex1373301373302026-04-30
05701780437561SenSura Mio Convex1680101680102026-04-30
05701780438384SenSura Mio Convex1680501680502026-04-30
05701780439923SenSura Mio Convex1682101682102026-04-30
05701780440462SenSura Mio Convex1682201682202026-04-30
05701780440875SenSura Mio Convex1682301682302026-04-30
05701780441292SenSura Mio Convex1682501682502026-04-30
05701780441926SenSura Mio Convex1682601682602026-04-30
05701780442572SenSura Mio Convex1682701682702026-04-30
05701780443074SenSura Mio Convex1683001683002026-04-30
05701780443371SenSura Mio Convex1683101683102026-04-30
05701780444026SenSura Mio Convex1683201683202026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05708932556569ColoplastColoplast 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
00852568002176umbili-CUTTERDivergent Medical Technologies LLcJOK2024-07-18
00852568002183umbili-CUTTERDivergent Medical Technologies LLcJOK2024-07-18