FDA.reportPublic FDA data

SmartBand EMR Pack

Primary DI
00850261006088
Brand
SmartBand EMR Pack
Company
INTELLIGENT ENDOSCOPY LLC
Model
SBEMRP
Catalog number
SBEMRP
Device description
SmartBand EMR Ligator Pack (10.75 mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable barrel of bands for procedures requiring more than 5 bands.
Published
2022-03-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDISNARE, FLEXIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212860000SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)STERIS Corporation2021-10-07FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850261006088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850261006088008502610060888502610060880850261006088

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal endoscopic ligator, single-useA device used in combination with a compatible flexible endoscope for the deployment of a rubber band to oesophageal varices during an endoscopic procedure which will create a haemostasis or necrosis of the varix. It is available in various designs and typically consists of a multiple band ligating unit that fits over the distal end of the endoscope with rubber latex ligating bands premounted on a band carrier, and controls that run along the outside of the endoscope terminating in a control handle at the proximal end that is used to deploy the bands as required. In some instances, this type of device could be used to treat haemorrhoids in the colon. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(336)608-4375info@intelligentendoscopy.com

Regulatory Flags#

DUNS number
046601986
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850261006125SmartSnare EMR Hexagonal SnareSS-230-1SS23012022-03-21
00850261006200SmartBand EMR PackSBEMRP94SBEMRP942022-03-21
00850261006217SmartBand EMR KitSBEMRK94SBEMRK942022-03-21
00850261006002SmartBand Ligation PackSLP-6IE110012017-08-01
00850261006019SmartBand Ligation KitSLK-6IE110022017-08-01
00850261006033SmartBand SafeGrip Multi-Band Ligation KitSLK-6-LFIE110042017-08-01
00850261006040SmartBand SafeGrip Multi-Band Ligation PackSLP-6-LFIE110032017-08-01
00850261006071SmartBand EMR KitSBEMRKSBEMRK2022-03-21
00850261006101SmartBand EMR KitSBEMRK12SBEMRK122022-03-21
00850261006118SmartBand EMR PackSBEMRP12SBEMRP122022-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995247317SmartBand EMR KitUS EndoscopyFDI2025-11-21
00724995247324SmartBand EMR PackUS EndoscopyFDI2025-11-21
00724995220051Roth NetUS EndoscopyFDI2024-11-25
00724995220068Roth Net PlatinumUS EndoscopyFDI2024-11-25
00724995194369CoinTipUS EndoscopyFDI2020-06-11
00724995194376CoinTipUS EndoscopyFDI2020-06-11
00724995194383CoinTipUS EndoscopyFDI2020-06-11
00724995182878HistolockUS EndoscopyFDI2020-04-02
00724995182908Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182915Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182922Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182939Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995180782iSnareUS EndoscopyFDI2020-03-19
00724995180799iSnareUS EndoscopyFDI2020-03-19
00724995180805iSnareUS EndoscopyFDI2020-03-19
00724995180812iSnareUS EndoscopyFDI2020-03-19
00724995180829iSnareUS EndoscopyFDI2020-03-19
00724995182472Short ThrowUS EndoscopyFDI2020-03-19
00724995182489Short ThrowUS EndoscopyFDI2020-03-19
00724995182496Roth NetUS EndoscopyFDI2020-03-19
00724995182502Roth NetUS EndoscopyFDI2020-03-19
00724995182519Roth NetUS EndoscopyFDI2020-03-19
00724995182526Roth NetUS EndoscopyFDI2020-03-19
00724995182533Roth NetUS EndoscopyFDI2020-03-19
00724995182540Polyp PakUS EndoscopyFDI2020-03-19
00724995182571LariatUS EndoscopyFDI2020-03-19
00724995182588LariatUS EndoscopyFDI2020-03-19
00724995182595Short ThrowUS EndoscopyFDI2020-03-19
00724995182601TraxtionUS EndoscopyFDI2020-03-19
00724995182625HistolockUS EndoscopyFDI2020-03-19