Flex-Ez Stylet Wire Balloon Dilator - A long, thin, flexible tube with an inflatable - HOBBS MEDICAL, INC.

Duns Number:076769355

Device Description: A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopi A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.

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More Product Details

Catalog Number

3758

Brand Name

Flex-Ez Stylet Wire Balloon Dilator

Version/Model Number

3758

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K834413

Product Code Details

Product Code

KNQ

Product Code Name

Dilator, Esophageal

Device Record Status

Public Device Record Key

0a47b435-3228-4588-93cb-0bbbd3ac3611

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOBBS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 196