FDA UDI
In Commercial Distribution
🇺🇸 United States
SmartBand SafeGrip Multi-Band Ligation Pack
DI: 00850261006040
·
Model: SLP-6-LF
·
INTELLIGENT ENDOSCOPY LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SmartBand SafeGrip Multi-Band Ligation Pack
- Primary DI
- 00850261006040
- Version / Model
- SLP-6-LF
- Catalog Number
- IE11003
- Company Name
- INTELLIGENT ENDOSCOPY LLC
- Labeler DUNS
- 046601986
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-01
- Public Version
- 3
- Public Version Date
- 2021-10-04
- Public Version Status
- Update
- Public Device Record Key
- e6d5ea42-df5a-494a-a690-acb3f60359e6
Device Description
Multi-Band Ligation Pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| MND | Ligator, esophageal | Gastroenterology, Urology | 876.4400 | 2 |
| FHN | Ligator, hemorrhoidal | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46680 | Oesophageal endoscopic ligator, single-use | A device used in combination with a compatible flexible endoscope for the deployment of a rubber band to oesophageal varices during an endoscopic procedure which will create a haemostasis or necrosis of the varix. It is available in various designs and typically consists of a multiple band ligating unit that fits over the distal end of the endoscope with rubber latex ligating bands premounted on a band carrier, and controls that run along the outside of the endoscope terminating in a control handle at the proximal end that is used to deploy the bands as required. In some instances, this type of device could be used to treat haemorrhoids in the colon. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850261006040 | GS1 |
Customer Contacts
- Phone
- +1(336)608-4375
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 0.625 | Inch | |
| Weight | 0.05 | Pound | |
| Height | 8 | Inch | |
| Width | 5.063 | Inch |