FDA UDI
In Commercial Distribution
🇺🇸 United States
Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm
DI: 03700512966203
·
Model: 09-0016
·
Promepla
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm
- Primary DI
- 03700512966203
- Version / Model
- 09-0016
- Catalog Number
- ROUS1235ST
- Company Name
- Promepla
- Labeler DUNS
- 401020409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-09
- Public Version
- 6
- Public Version Date
- 2024-01-15
- Public Version Status
- Update
- Public Device Record Key
- 4bed471e-d866-49f4-919c-c01c3890786e
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| KNY | Accessories, Catheter, G-U | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34926 | Ureteral catheter | A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03700512986201 | GS1 | Box | 5 | In Commercial Distribution | |
| Package | 03700512976202 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 03700512966203 | GS1 |
Customer Contacts
- Phone
- +37797984232
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140441 | 000 |