FDA UDI
In Commercial Distribution
🇺🇸 United States
Single-use Extraction Baskets
DI: 06971381251647
·
Model: EBT-08
·
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Single-use Extraction Baskets
- Primary DI
- 06971381251647
- Version / Model
- EBT-08
- Company Name
- SCIVITA MEDICAL TECHNOLOGY CO., LTD.
- Labeler DUNS
- 544519831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-24
- Public Version
- 1
- Public Version Date
- 2023-06-01
- Public Version Status
- New
- Public Device Record Key
- f1dd495f-720d-403d-ace2-29e175f11926
Device Description
The single-use extraction baskets is used in combination with the endoscope, entering from the urinary endoscopic channel, passing through the urethra and bladder, entering the ureter, trapping stones and foreign bodies through the basket ring, and then firmly grasping stones and foreign bodies through the basket contraction, and removing stones and foreign bodies.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 06971381251647 | GS1 | ||||
| Package | 16971381251644 | GS1 | 1 | In Commercial Distribution | ||
| Package | 26971381251641 | GS1 | 36 | In Commercial Distribution |