FDA.reportPublic FDA data

SmartBand SafeGrip Multi-Band Ligation Pack

Primary DI
00850261006040
Brand
SmartBand SafeGrip Multi-Band Ligation Pack
Company
INTELLIGENT ENDOSCOPY LLC
Model
SLP-6-LF
Catalog number
IE11003
Device description
Multi-Band Ligation Pack
Published
2017-08-01
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
FHNLigator, hemorrhoidal
MNDLigator, esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHNLigator, HemorrhoidalGastroenterology, Urology2
MNDLigator, EsophagealGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850261006040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850261006040008502610060408502610060400850261006040

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
Depth0.625Inch
Height8Inch
Weight0.05Pound
Width5.063Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
046601986
Device count
1
Premarket exempt
true
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
00850261006071SmartBand EMR KitSBEMRKSBEMRK2022-03-21
00850261006088SmartBand EMR PackSBEMRPSBEMRP2022-03-21
00850261006101SmartBand EMR KitSBEMRK12SBEMRK122022-03-21
00850261006118SmartBand EMR PackSBEMRP12SBEMRP122022-03-21

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