RotoNet RT-NET-4-230-5

GUDID 10816207021376

Endoscopic Retrieval Net - Maxi, Colonic

ENDO-THERAPEUTICS, INC.

Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use Gastrointestinal/airway foreign body retrieval basket, single-use
Primary Device ID10816207021376
NIH Device Record Keyacccc3ad-aea5-4c3f-9ea6-28feb8df6b53
Commercial Distribution StatusIn Commercial Distribution
Brand NameRotoNet
Version Model NumberRT-NET-4-230-5
Catalog NumberRT-NET-4-230-5
Company DUNS825239189
Company NameENDO-THERAPEUTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com

Device Dimensions

Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter
Device Size Text, specify0
Length230 Centimeter
Device Size Text, specify0
Outer Diameter3 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100816207021379 [Primary]
GS110816207021376 [Package]
Contains: 00816207021379
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

FGXSnare, Non-Electrical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-19
Device Publish Date2023-07-11

On-Brand Devices [RotoNet]

10816207021376Endoscopic Retrieval Net - Maxi, Colonic
10816207021369Endoscopic Retrieval Net - Maxi, Esophageal
10816207021352Endoscopic Retrieval Net - Standard, Enteroscope
10816207021345Endoscopic Retrieval Net - Standard, Colonic
10816207021338Endoscopic Retrieval Net - Standard, Esophageal
10816207021321Endoscopic Retrieval Net - Mini

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.