Attachable Suture Wing - 9.5FR SUTURE WING PK - Bard Access Systems, Inc.

Duns Number:044611812

Device Description: 9.5FR SUTURE WING PK

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More Product Details

Catalog Number

6660016

Brand Name

Attachable Suture Wing

Version/Model Number

6660016

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

355b0a0f-1a28-43d1-92ec-c1e4b75bcb10

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Additional Identifiers

Package DI Number

10801741075145

Quantity per Package

10

Contains DI Package

00801741075148

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"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