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RotoNet

FDA UDI

Class I (US FDA UDI)

by Endo-Therapeutics, Inc.

Identity

Trade Name
RotoNet FDA UDI
Generic Name
Gastrointestinal/airway foreign body retrieval basket, single-use FDA UDI
Device Name
Endoscopic Retrieval Net - Maxi, Esophageal FDA UDI
Model / Reference
RT-NET-4-160-5 FDA UDI
Description
Endoscopic Retrieval Net - Maxi, Esophageal FDA UDI

Identifiers

Catalog Number
RT-NET-4-160-5 FDA UDI
Primary DI / UDI-DI
00816207021362 FDA UDI
FDA Product Code
FGX FDA UDI
GMDN Term
Gastrointestinal/airway foreign body retrieval basket, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.4730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 160 Centimeter FDA UDI
Outer Diameter — 3.0 Millimeter FDA UDI

Category: Gastrointestinal/airway foreign body retrieval basket, single-use

RotoNet by Endo-Therapeutics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal/airway foreign body retrieval basket, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endo-Therapeutics, Inc.

Sources (1)

  • FDA UDI d41b60d1-7f26-4904-85a5-e1cbfb7cbe8d 37 fields · synced May 30, 2026