FDA UDI
In Commercial Distribution
🇺🇸 United States
Insertion Tool
DI: 05708932767521
·
Model: NTER01
·
COLOPLAST CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Insertion Tool
- Primary DI
- 05708932767521
- Version / Model
- NTER01
- Catalog Number
- NTER01
- Company Name
- COLOPLAST CORP.
- Labeler DUNS
- 847436391
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-27
- Public Version
- 1
- Public Version Date
- 2024-10-07
- Public Version Status
- New
- Public Device Record Key
- 884ab3ce-6d3b-4be2-a572-afe13dd5b620
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGZ | ACCESSORIES, CATHETER | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61944 | Guidewire holder | A sterile tubular device intended to be used for the storage and retrieval of one or more guidewires within the sterile field during a procedure. It is typically a long (approximately three metres) tube, that can be secured to surgical drapes, with a funnel-shaped proximal end and sometimes a sealed, vented distal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05708932767545 | GS1 | Shipper Box | 8 | In Commercial Distribution | |
| Package | 05708932767538 | GS1 | Retail Box | 35 | In Commercial Distribution | |
| Primary | 05708932767521 | GS1 |
Customer Contacts
- Phone
- +1(800)258-3476
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter Inner - Fr 3.1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from rain. Keep away from sunlight.