FDA UDI
In Commercial Distribution
🇺🇸 United States
Tipless Basket
DI: 03700512968214
·
Model: ROSZ1300ST245
·
Promepla
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Tipless Basket
- Primary DI
- 03700512968214
- Version / Model
- ROSZ1300ST245
- Catalog Number
- TIPL1300
- Company Name
- Promepla
- Labeler DUNS
- 401020409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-24
- Public Version
- 1
- Public Version Date
- 2021-03-04
- Public Version Status
- New
- Public Device Record Key
- a0be3368-23ad-481e-97ec-9bc3dd7f4648
Device Description
1.3 Fr Basket
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
- 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 |
|---|---|---|---|---|
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Gastroenterology, Urology | 876.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46452 | Biliary/urinary stone retrieval basket, single-use | A flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an open surgical and/or endoscopic/laparoscopic procedure [e.g., choledochoscopy, endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03700512978213 | GS1 | Box 1 | 1 | In Commercial Distribution | |
| Primary | 03700512968214 | GS1 | ||||
| Package | 03700512988212 | GS1 | Box 2 | 4 | In Commercial Distribution |