Freeman Pancreatic Flexi-Stent Kit - Pancreatic Flexi-Stent Kit includes Stent and - HOBBS MEDICAL, INC.

Duns Number:076769355

Device Description: Pancreatic Flexi-Stent Kit includes Stent and Pusher Catheter. This is a single-use device Pancreatic Flexi-Stent Kit includes Stent and Pusher Catheter. This is a single-use device.

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More Product Details

Catalog Number

6517

Brand Name

Freeman Pancreatic Flexi-Stent Kit

Version/Model Number

6517

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

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

K834351

Product Code Details

Product Code

FGE

Product Code Name

Catheter, Biliary, Diagnostic

Device Record Status

Public Device Record Key

8ec2c056-fc2d-4980-a563-ad54d586eed4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 05, 2017

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