FDA UDI
In Commercial Distribution
🇺🇸 United States
RotoNet
DI: 00816207021331
·
Model: RT-NET-3-160-5
·
ENDO-THERAPEUTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- RotoNet
- Primary DI
- 00816207021331
- Version / Model
- RT-NET-3-160-5
- Catalog Number
- RT-NET-3-160-5
- Company Name
- ENDO-THERAPEUTICS, INC.
- Labeler DUNS
- 825239189
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-11
- Public Version
- 1
- Public Version Date
- 2023-07-19
- Public Version Status
- New
- Public Device Record Key
- a9fe7c3d-bdfd-4da9-8333-0749215a6ea9
Device Description
Endoscopic Retrieval Net - Standard, Esophageal
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FGX | Snare, Non-Electrical | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46454 | Gastrointestinal/airway foreign body retrieval basket, single-use | A flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). It is typically designed with a long, thin, flexible body that has an expandable basket at the distal end in which objects are caught for extraction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816207021338 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 00816207021331 | GS1 |
Customer Contacts
- Phone
- 844-400-3636
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 160 | Centimeter | |
| Device Size Text, specify | Min. Channel 2.8 mm | ||
| Device Size Text, specify | Net Size: 3.0 cm x 6.0 cm | ||
| Outer Diameter | 2.5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry