FDA UDI
In Commercial Distribution
🇺🇸 United States
SmartBand EMR Pack
DI: 00724995247324
·
Model: SBEMRP94
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SmartBand EMR Pack
- Primary DI
- 00724995247324
- Version / Model
- SBEMRP94
- Catalog Number
- SBEMRP94
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-21
- Public Version
- 1
- Public Version Date
- 2025-12-01
- Public Version Status
- New
- Public Device Record Key
- e96b33cc-14bf-466c-8793-11dd83283a5e
Device Description
SmartBand EMR Ligator Pack 9.4 mm is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable barrel of bands for procedures requiring more than 5 bands.
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
- 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 |
|---|---|---|---|---|
| FDI | SNARE, FLEXIBLE | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61613 | Endoscopic electrosurgical mucosal biopsy/resection set | A collection of devices designed to be used during an endoscopic mucosal tissue biopsy and/or therapeutic resection procedure to: 1) isolate a specified section of mucosa using endoscopic suction and application of ligature bands; and 2) resect the lesion using monopolar electrosurgical energy. It consists of a ligation unit with distally-mounted bands and a flexible electrosurgical snare. Suction is applied to retract the tissue into the ligator cap, the ligature band(s) are then deployed, followed by electrosurgical resection of the tissue with the snare. Disposable devices for histological sample processing (e.g., biowraps) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995247324 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212860 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 9.4mm barrel tip diameter |