Busse Hospital Disposables - Dr. Bukhalo's Single Shot Epidural Tray - 22 Gauge - ROBERT BUSSE & CO., INC.

Duns Number:002418234

Device Description: Dr. Bukhalo's Single Shot Epidural Tray - 22 Gauge

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More Product Details

Catalog Number

6149

Brand Name

Busse Hospital Disposables

Version/Model Number

6149

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

-

Product Code Details

Product Code

OGJ

Product Code Name

Nerve Block Tray

Device Record Status

Public Device Record Key

e88b60ec-8bd6-4827-ac36-5bbf8bdb293e

Public Version Date

March 26, 2020

Public Version Number

5

DI Record Publish Date

September 13, 2016

Additional Identifiers

Package DI Number

10849233017570

Quantity per Package

10

Contains DI Package

00849233017573

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