SmartBand Ligation Pack IE11001

GUDID 00850261006002

Multi-Band Ligation Pack

INTELLIGENT ENDOSCOPY LLC

Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use
Primary Device ID00850261006002
NIH Device Record Key2cdc020f-4e69-42fa-8ed1-c28531e969d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartBand Ligation Pack
Version Model NumberSLP-6
Catalog NumberIE11001
Company DUNS046601986
Company NameINTELLIGENT ENDOSCOPY LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
Labeled No Natural Rubber Latexfalse
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
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

Height8 Inch
Height8 Inch
Height8 Inch
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch
Depth0.625 Inch
Width5.063 Inch
Weight0.05 Pound
Height8 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100850261006002 [Primary]

FDA Product Code

FHNLigator, hemorrhoidal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-08-01

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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.
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00850261006002 - SmartBand Ligation Pack2018-03-29 Multi-Band Ligation Pack
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