Attachable Suture Wing - 5 Fr. Suture Wings - Bard Access Systems, Inc.

Duns Number:044611812

Device Description: 5 Fr. Suture Wings

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More Product Details

Catalog Number

6660017

Brand Name

Attachable Suture Wing

Version/Model Number

6660017

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

KMK

Product Code Name

DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Device Record Status

Public Device Record Key

bbf7ca43-9afa-4ffc-b792-3c5f42371cae

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Additional Identifiers

Package DI Number

20801741075159

Quantity per Package

54

Contains DI Package

10801741075152

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX

"BARD ACCESS SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 3348
U Unclassified 8