SmartBand EMR Kit - SmartBand EMR Kit (10.75mm) is indicated for - INTELLIGENT ENDOSCOPY LLC

Duns Number:046601986

Device Description: SmartBand EMR Kit (10.75mm) is indicated for endoscopic mucosal resection in the upper GI SmartBand EMR Kit (10.75mm) is indicated for endoscopic mucosal resection in the upper GI tract.

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More Product Details

Catalog Number

SBEMRK

Brand Name

SmartBand EMR Kit

Version/Model Number

SBEMRK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K212860

Product Code Details

Product Code

FDI

Product Code Name

SNARE, FLEXIBLE

Device Record Status

Public Device Record Key

b34cdfc7-a889-44a4-9a3c-d85b0aab190d

Public Version Date

March 29, 2022

Public Version Number

1

DI Record Publish Date

March 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTELLIGENT ENDOSCOPY LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11