FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Lariat
DI: 00816765015247
·
Model: 00711097
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Lariat
- Primary DI
- 00816765015247
- Version / Model
- 00711097
- Catalog Number
- 00711097
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-19
- Public Version
- 4
- Public Version Date
- 2024-08-07
- Public Version Status
- Update
- Public Device Record Key
- 9d96a98c-0353-4d21-8354-bbdc3ec2091d
- Distribution End Date
- 2020-03-17
Device Description
The Lariat snare is an electrosurgical device designed to be used to endoscopically grasp, dissect, and transect tissue during Gastrointestinal (GI) endoscopic procedures.
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 |
|---|---|---|---|---|
| FDI | SNARE, FLEXIBLE | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58039 | Endoscopic electrosurgical handpiece/electrode, monopolar, single-use | An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816765015244 | GS1 | Box | 50 | Not in Commercial Distribution | 2020-03-17 |
| Primary | 00816765015247 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151197 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2 | Millimeter | |
| Length | 230 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius