Busse Hospital Disposables - Sterile Epiglide Tuohy Needle 18G x 3.5" with - ROBERT BUSSE & CO., INC.

Duns Number:002418234

Device Description: Sterile Epiglide Tuohy Needle 18G x 3.5" with Fixed wings

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

581

Brand Name

Busse Hospital Disposables

Version/Model Number

581

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"

Yes

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

K131006,K131006,K131006

Product Code Details

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Device Record Status

Public Device Record Key

f0173c08-f437-4c1e-8ab0-6971ee807ba5

Public Version Date

October 07, 2021

Public Version Number

1

DI Record Publish Date

September 29, 2021

Additional Identifiers

Package DI Number

10849233005768

Quantity per Package

25

Contains DI Package

00849233005761

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ROBERT BUSSE & CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 298