FDA UDI
In Commercial Distribution
🇺🇸 United States
iSnare
DI: 00724995180799
·
Model: 00711085
·
US Endoscopy
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- iSnare
- Primary DI
- 00724995180799
- Version / Model
- 00711085
- Catalog Number
- 00711085
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-19
- Public Version
- 2
- Public Version Date
- 2020-11-10
- Public Version Status
- Update
- Public Device Record Key
- f912c139-47d6-4c4d-b8ba-b7bb235e0676
Device Description
The iSnare system is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device.
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FBK | endoscopic injection needle, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 2 |
| FDI | SNARE, FLEXIBLE | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46632 | Endoscopic electrosurgical submucosal lift/resection set | A collection of devices designed to be used during an endoscopic mucosal resection procedure to: 1) lift a section of diseased mucosa by injection of a submucosal lifting solution; and 2) resect the lesion using monopolar electrosurgical energy; it may in addition include devices designed to perform vacuum elevation of the lesion to supplement submucosal lifting. It includes a submucosal injection needle, an electrosurgical electrode (e.g., polyp snare), and might include additional supportive devices such as a dye spray catheter and endoscope suction cap. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10724995180796 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 00724995180799 | GS1 | ||||
| Previous | 00816765010914 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 23 | Gauge | |
| Width | 2.5 | Millimeter | |
| Length | 230 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry