Identity
- Trade Name
- Roth Net Platinum FDA UDI
- Generic Name
- Gastrointestinal/airway foreign body retrieval basket, single-use FDA UDI
- Device Name
- The disposable Roth Net Platinum universal retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps. FDA UDI
- Model / Reference
- 715051 FDA UDI
- Description
- The disposable Roth Net Platinum universal retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps. FDA UDI
Identifiers
- Catalog Number
- 00715051 FDA UDI
- Primary DI / UDI-DI
- 00724995220068 FDA UDI
- FDA Product Code
- GCJ FDA UDIFDI FDA UDI
- GMDN Term
- Gastrointestinal/airway foreign body retrieval basket, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI876.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.5 Millimeter FDA UDILength — 230 Centimeter FDA UDIWidth — 4 Centimeter FDA UDI
Category: Gastrointestinal/airway foreign body retrieval basket, single-use
Roth Net Platinum by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal/airway foreign body retrieval basket, single-use.
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- EndoTBasket — ENDO-THERAPEUTICS, INC. · Class II
Cleared under the same submission
K182909 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- US Endoscopy
Sources (1)
- FDA UDI f5bd6bd3-6a98-40be-8af9-f97620ee4f18 38 fields · synced May 31, 2026