FDA UDI
In Commercial Distribution
🇺🇸 United States
Well Lead Extraction Bag
DI: 06936881133756
·
Model: O02A010810
·
Well Lead Medical Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Well Lead Extraction Bag
- Primary DI
- 06936881133756
- Version / Model
- O02A010810
- 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
- 8214cedc-fee6-4602-93a5-45d835a5add4
Device Description
Type A 800ml
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
- No
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56731 | Surgical tissue/fluid collection bag | A flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06936881133756 | GS1 | ||||
| Package | 16936881133753 | GS1 | Box | 5 | In Commercial Distribution | |
| Package | 26936881133750 | GS1 | Carton | 20 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160801 | 000 |