FDA UDI
In Commercial Distribution
🇺🇸 United States
LHC Power Bander
DI: 00860014651106
·
Model: LHC_V126
·
LHC Power Bander LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LHC Power Bander
- Primary DI
- 00860014651106
- Version / Model
- LHC_V126
- Company Name
- LHC Power Bander LLC
- Labeler DUNS
- 144915425
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-03
- Public Version
- 1
- Public Version Date
- 2026-03-11
- Public Version Status
- New
- Public Device Record Key
- 0f35c3de-a24c-4211-a163-fbdfadb9fd50
Device Description
Single use hemorrhoid ligation device. Clean, non sterile non implantable rubber bander to remove internal hemorrhoids.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 | 00860014651113 | GS1 | box | 20 | In Commercial Distribution | |
| Primary | 00860014651106 | GS1 |