Catalog Number

BCD-10

Brand Name

Ambler Surgical

Version/Model Number

BCD-10

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K831236,K831236

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

b185b603-d7bf-4b3e-b18e-93e4cfe218b4

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

00190660000875

Quantity per Package

10

Contains DI Package

10190660000872

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX