Catalog Number

BDC-15

Brand Name

Capseus Surgical

Version/Model Number

BDC-15

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GCX

Product Code Name

APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Public Device Record Key

8361e694-f717-4ade-bc0c-8adcf62ce837

Public Version Date

May 23, 2022

Public Version Number

3

DI Record Publish Date

October 23, 2019

Package DI Number

30665973027112

Quantity per Package

4

Contains DI Package

20665973027115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case