FDA.reportPublic FDA data

RotoNet

Primary DI
10816207021321
Brand
RotoNet
Company
ENDO-THERAPEUTICS, INC.
Model
RT-NET-2-160-5
Catalog number
RT-NET-2-160-5
Device description
Endoscopic Retrieval Net - Mini
Published
2023-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGXSnare, Non-Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGXSnare, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816207021321PackageGS15In Commercial Distribution
00816207021324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081620702132110816207021321
00816207021324008162070213248162070213240816207021324

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/airway foreign body retrieval basket, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length160Centimeter
Outer Diameter1.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-400-3636customerservice@endotherapeutics.com

Regulatory Flags#

DUNS number
825239189
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816207021744EndoTExtractorET2070ET20702026-03-03
10816207021741EndoTExtractorET2070ET20702026-03-03
00816207021386EndoTBasketET2046ET20462025-02-26
10816207021383EndoTBasketET2046ET20462025-02-26
00816207021720Biopsy BrushLBB-95LBB-952025-02-26
00816207020181BioCeps Biopsy ForcepsET1400ET14002016-09-22
00816207020242ezSnare Polypectomy SnareET1800ET18002016-09-22
00816207020259ezSnare Polypectomy SnareET1801ET18012016-09-22
00816207020266ezSnare Polypectomy SnareET1802ET18022016-09-22
00816207020273ezSnare Polypectomy SnareET1803ET18032016-09-22
00816207020280ezSnare Polypectomy SnareET1804ET18042016-09-22
00816207020297ezSnare Polypectomy SnareET1805ET18052016-09-22
00816207020303ezSnare Polypectomy SnareET1806ET18062016-09-22
00816207020310ezSnare Polypectomy SnareET1807ET18072016-09-22
00816207020327ezSnare Polypectomy SnareET1814ET18142016-09-22
00816207020624Polypectomy Snare, Oval-LargeSGO-1315LSGO-1315L2016-09-20
00816207020631Polypectomy Snare, Oval - MediumSGO-1315MSGO-1315M2016-09-20
00816207020648Polypectomy Snare, Oval - SmallSGO-1315SSGO-1315S2016-09-20
00816207020655Polypectomy Snare, Oval - Extra LargeSGO-1315XLSGO-1315XL2016-09-20
00816207020662Polypectomy Snare, Oval - LargeSGO-1622LSGO-1622L2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664902073NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902097NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902110NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902127NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902134NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902141NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902158NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902172NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902196NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902202NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902219NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902226NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902233NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902240NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902257NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902264NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902271NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902288NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902295NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902301NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908921NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908938NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908945NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908952NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908983NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908990NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909003NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909027NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909034NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909041NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22