FDA UDI
In Commercial Distribution
🇺🇸 United States
LEM
DI: 08033638802328
·
Model: Suction LEM with bands
·
SAPI MED SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- LEM
- Primary DI
- 08033638802328
- Version / Model
- Suction LEM with bands
- Catalog Number
- A.5650.3
- Company Name
- SAPI MED SPA
- Labeler DUNS
- 437320088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-27
- Public Version
- 1
- Public Version Date
- 2023-08-04
- Public Version Status
- New
- Public Device Record Key
- e26e9ddd-64e8-46f7-8d03-afe1d16eb3f4
Device Description
LEM - Disposable haemorrhoid banding ligator for use with suction complete with 3 latex bands.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FHN | Ligator, Hemorrhoidal | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35157 | Haemorrhoid ligator | A hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08033638802335 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 08033638802328 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070881 | 000 |