FDA UDI
In Commercial Distribution
🇺🇸 United States
Self-Suction-LEM
DI: 08033638801710
·
Model: Self-Suction-LEM
·
SAPI MED SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Self-Suction-LEM
- Primary DI
- 08033638801710
- Version / Model
- Self-Suction-LEM
- Catalog Number
- A.5670
- Company Name
- SAPI MED SPA
- Labeler DUNS
- 437320088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-06
- Public Version
- 1
- Public Version Date
- 2026-02-16
- Public Version Status
- New
- Public Device Record Key
- fa67550c-5da7-42bb-a0b0-c57e09fb49b6
Device Description
Self-Suction-LEM - Single-patient device for suction band ligation of hemorrhoids and no need for an external surgical aspirator.
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
- 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 |
|---|---|---|---|---|
| 46878 | Haemorrhoid ligation set | A collection of sterile surgical instruments and materials used to locally occlude the blood flow to internal haemorrhoids for their removal. The collection typically includes a ligator preloaded with several ligatures (e.g., latex rubber bands) deployed to the haemorrhoids, an anoscope used to dilate the anus for internal access, and an obturator for insertion of the anoscope. After a ligature has been applied, the haemorrhoid will eventually necrose and pass out of the gut naturally. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08033638801727 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 08033638801710 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070881 | 000 |