Bard® PTFE Felt - Bard® PTFE Felt, 5.1 cm x 5.1 cm - Bard Peripheral Vascular, Inc.

Duns Number:135057938

Device Description: Bard® PTFE Felt, 5.1 cm x 5.1 cm

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More Product Details

Catalog Number

007977

Brand Name

Bard® PTFE Felt

Version/Model Number

007977

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

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

-

Product Code Details

Product Code

DXZ

Product Code Name

PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Device Record Status

Public Device Record Key

9ba649b3-64f0-4d08-b52c-bb2275858b86

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

September 25, 2015

Additional Identifiers

Package DI Number

10801741041416

Quantity per Package

10

Contains DI Package

00801741041419

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"BARD PERIPHERAL VASCULAR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 2835
3 A medical device with high risk that requires premarket approval 190