FDA UDI
In Commercial Distribution
🇺🇸 United States
Coloplast
DI: 05708932556569
·
Model: 95050
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Coloplast
- Primary DI
- 05708932556569
- Version / Model
- 95050
- Catalog Number
- 95050
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-23
- Public Version
- 1
- Public Version Date
- 2024-09-02
- Public Version Status
- New
- Public Device Record Key
- 7734c516-5e95-420b-9b89-9400383eb5c7
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOK | SCISSORS, MEDICAL, DISPOSABLE | General Hospital | 880.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64247 | Ostomy appliance scissors | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05708932556576 | GS1 | Shipper Box | 12 | In Commercial Distribution | |
| Package | 05708932556583 | GS1 | Retail Box | 30 | In Commercial Distribution | |
| Primary | 05708932556569 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.