SmartSnare EMR Hexagonal Snare SS2301

GUDID 00850261006125

SmartSnare EMR Hexagonal Snare supports resection of target pseudopolyp with its ultra-slim snare wire diameter and controlled rotation designed to facilitate placement around the band.

INTELLIGENT ENDOSCOPY LLC

Mechanical-cutting endoscopic polypectomy snare Mechanical-cutting endoscopic polypectomy snare Mechanical-cutting endoscopic polypectomy snare Mechanical-cutting endoscopic polypectomy snare Mechanical-cutting endoscopic polypectomy snare Mechanical-cutting endoscopic polypectomy snare Mechanical-cutting endoscopic polypectomy snare Mechanical-cutting endoscopic polypectomy snare Mechanical-cutting endoscopic polypectomy snare Mechanical-cutting endoscopic polypectomy snare Mechanical-cutting endoscopic polypectomy snare Mechanical-cutting endoscopic polypectomy snare
Primary Device ID00850261006125
NIH Device Record Keyd6b28379-bbeb-4b6a-8a3e-9fb385a6c86b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartSnare EMR Hexagonal Snare
Version Model NumberSS-230-1
Catalog NumberSS2301
Company DUNS046601986
Company NameINTELLIGENT ENDOSCOPY LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com
Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com
Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com
Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com
Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com
Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com
Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com
Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com
Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com
Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com
Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com
Phone+1(336)608-4375
Emailinfo@intelligentendoscopy.com

Device Dimensions

Length230 Centimeter
Width15 Millimeter
Length230 Centimeter
Width15 Millimeter
Length230 Centimeter
Width15 Millimeter
Length230 Centimeter
Width15 Millimeter
Length230 Centimeter
Width15 Millimeter
Length230 Centimeter
Width15 Millimeter
Length230 Centimeter
Width15 Millimeter
Length230 Centimeter
Width15 Millimeter
Length230 Centimeter
Width15 Millimeter
Length230 Centimeter
Width15 Millimeter
Length230 Centimeter
Width15 Millimeter
Length230 Centimeter
Width15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850261006125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDISNARE, FLEXIBLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-29
Device Publish Date2022-03-21

Devices Manufactured by INTELLIGENT ENDOSCOPY LLC

00850261006071 - SmartBand EMR Kit2022-03-29 SmartBand EMR Kit (10.75mm) is indicated for endoscopic mucosal resection in the upper GI tract.
00850261006088 - SmartBand EMR Pack2022-03-29 SmartBand EMR Ligator Pack (10.75 mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadabl
00850261006101 - SmartBand EMR Kit2022-03-29 SmartBand EMR Kit (12mm) is indicated for endoscopic mucosal resection in the upper GI tract.
00850261006118 - SmartBand EMR Pack2022-03-29 SmartBand EMR Ligator Pack (12mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable b
00850261006125 - SmartSnare EMR Hexagonal Snare2022-03-29SmartSnare EMR Hexagonal Snare supports resection of target pseudopolyp with its ultra-slim snare wire diameter and controlled rotation designed to facilitate placement around the band.
00850261006125 - SmartSnare EMR Hexagonal Snare2022-03-29 SmartSnare EMR Hexagonal Snare supports resection of target pseudopolyp with its ultra-slim snare wire diameter and controlled r
00850261006200 - SmartBand EMR Pack2022-03-29 SmartBand EMR Ligator Pack (9.4 mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable
00850261006217 - SmartBand EMR Kit2022-03-29 The SmartBand EMR Kit (9.4mm) is indicated for endoscopic mucosal resection in the upper GI tract.
00850261006002 - SmartBand Ligation Pack2018-03-29 Multi-Band Ligation Pack
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.