PILLING - MALONEY TUNGSTEN FILLED BOUGIE 56F - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: MALONEY TUNGSTEN FILLED BOUGIE 56F

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More Product Details

Catalog Number

507956

Brand Name

PILLING

Version/Model Number

IPN008075

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"

-

For Single-Use

-

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

-

Product Code Details

Product Code

FAT

Product Code Name

Bougie, esophageal, and gastrointestinal, gastro-urology

Device Record Status

Public Device Record Key

49d94a13-4b9b-4f5c-9845-366098d1666b

Public Version Date

July 07, 2020

Public Version Number

7

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

44026704417429

Quantity per Package

10

Contains DI Package

24026704417425

Package Discontinue Date

June 26, 2020

Package Status

Not in Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26