FDA UDI
In Commercial Distribution
🇺🇸 United States
Wellead Urethral Dilator
DI: 06936881136474
·
Model: U02A082610
·
Well Lead Medical Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Wellead Urethral Dilator
- Primary DI
- 06936881136474
- Version / Model
- U02A082610
- Company Name
- Well Lead Medical Co.,Ltd
- Labeler DUNS
- 544811862
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-12
- Public Version
- 1
- Public Version Date
- 2023-07-20
- Public Version Status
- New
- Public Device Record Key
- ad2631e7-7224-4523-ae4e-fc5510fb60b1
Device Description
Urethral Dilator Straight, Hydrophilic coated 26Fr
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
- Yes
- 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 |
|---|---|---|---|---|
| KOE | Dilator, Urethral | Gastroenterology, Urology | 876.5520 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64677 | Urethral dilator, single-use | A slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16936881136471 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 06936881136474 | GS1 | ||||
| Package | 26936881136478 | GS1 | Carton | 10 | In Commercial Distribution |