SmartBand Ligation Kit IE11002

GUDID 00850261006019

Multi-Band Ligation Kit

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 ID00850261006019
NIH Device Record Key2087a78a-e0f8-4f55-aebf-906c10c54651
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartBand Ligation Kit
Version Model NumberSLK-6
Catalog NumberIE11002
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

Width10.875 Inch
Width10.875 Inch
Width10.875 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch
Height13.938 Inch
Weight0.25 Pound
Depth1.938 Inch
Width10.875 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100850261006019 [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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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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