PILLING - ROMMEL THORASIC FCP HORIZ SER 9" "B" - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: ROMMEL THORASIC FCP HORIZ SER 9" "B"

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More Product Details

Catalog Number

P13416

Brand Name

PILLING

Version/Model Number

IPN017081

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

DWS

Product Code Name

INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Device Record Status

Public Device Record Key

02df7d67-f319-4be4-aed7-dbb8051f07b1

Public Version Date

May 01, 2020

Public Version Number

1

DI Record Publish Date

April 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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