FDA UDI
In Commercial Distribution
🇺🇸 United States
Ligation Device
DI: 06923646508638
·
Model: Loop15B0-LD165D0
·
Leo Medical Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ligation Device
- Primary DI
- 06923646508638
- Version / Model
- Loop15B0-LD165D0
- Catalog Number
- Loop15B0-LD165D0
- Company Name
- Leo Medical Co., Ltd.
- Labeler DUNS
- 421371962
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-18
- Public Version
- 1
- Public Version Date
- 2025-12-26
- Public Version Status
- New
- Public Device Record Key
- 24aa246d-f756-4731-b0f3-cf68eb974cf1
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
- 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 |
|---|---|---|---|---|
| FHN | Ligator, Hemorrhoidal | Gastroenterology, Urology | 876.4400 | 2 |
| MND | Ligator, Esophageal | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38719 | Polypectomy endoscopic ligator, single-use | A device used in combination with a compatible flexible endoscope for the deployment of a ligature loop (a self-locking device made of, e.g., a polymer in the form of a thin band) that is typically applied to large colorectal or pedunculated polyps in the gastrointestinal (GI) tract to prevent or control bleeding following polypectomy. It typically consists of an insertion sheath, the ligature loop at the distal end, and a control handle at the proximal end used to deploy the loop. This device may be used to ligate the appendix during its removal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06923646508638 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172985 | 000 |