NA - Chiba Fine Needle Aspiration 22G X 15CM - Bard Peripheral Vascular, Inc.

Duns Number:135057938

Device Description: Chiba Fine Needle Aspiration 22G X 15CM

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More Product Details

Catalog Number

CHI2215

Brand Name

NA

Version/Model Number

CHI2215

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

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Device Record Status

Public Device Record Key

98b48ef8-8707-4bcb-b8b7-71fab2a88ac9

Public Version Date

February 18, 2021

Public Version Number

4

DI Record Publish Date

July 18, 2018

Additional Identifiers

Package DI Number

50885403088931

Quantity per Package

10

Contains DI Package

10885403088933

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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