FDA UDI
In Commercial Distribution
🇺🇸 United States
Dila-Cath Nelaton 40cm CH16
DI: 07333387040936
·
Model: 40616
·
Wellspect AB
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Dila-Cath Nelaton 40cm CH16
- Primary DI
- 07333387040936
- Version / Model
- 40616
- Catalog Number
- 4061600
- Company Name
- Wellspect AB
- Labeler DUNS
- 351118942
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-01
- Public Version
- 2
- Public Version Date
- 2023-09-15
- Public Version Status
- Update
- Public Device Record Key
- c1b546d6-22c3-4bd3-88c7-7ec55ee0d46e
Device Description
Urinary catheter for intermittent dilatation
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 |
|---|---|---|---|---|
| FBX | SOUND, URETHRAL, METAL OR PLASTIC | Gastroenterology, Urology | 876.5520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32022 | Urethral dilatation catheter, non-medicated | A sterile, flexible or semi-flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage. The device is typically made of plastic and silicone materials and is available in a variety of designs whereby: 1) it may have a larger diameter than that of a normal urethra; 2) it may have an attached inflatable balloon; or 3) the leading end of the device may be moulded into an extremely slender or thread-shaped form in order to facilitate passage of a larger, following portion; it does not elute a drug. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07333387040950 | GS1 | 2 | In Commercial Distribution | ||
| Package | 07333387040943 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 07333387040936 | GS1 | ||||
| Previous | 07392532131707 | GS1 |
Customer Contacts
- Phone
- +1(877)456-3742
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 40 | Centimeter | |
| Catheter Gauge | 16 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place at room temperature.