FDA UDI
In Commercial Distribution
🇺🇸 United States
Short Throw
DI: 00724995182472
·
Model: 00711018
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Short Throw
- Primary DI
- 00724995182472
- Version / Model
- 00711018
- Catalog Number
- 00711018
- 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
- c319fe23-0d7f-47b4-89c3-1572cdcedcf8
Device Description
The Short Throw snare is an electrosurgical device used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy.
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 |
|---|---|---|---|---|
| 58051 | Uterine manipulator, single-use | A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10724995182479 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00724995182472 | GS1 | ||||
| Previous | 00816765010839 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 230 | Centimeter | |
| Outer Diameter | 2.4 | Millimeter | |
| Width | 1 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry