ZEOS - ZEOS HD CAMERA CONTROL UNIT, JPN - SANTA BARBARA IMAGING SYSTEMS, INC.

Duns Number:065016344

Device Description: ZEOS HD CAMERA CONTROL UNIT, JPN

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More Product Details

Catalog Number

84-10-2410

Brand Name

ZEOS

Version/Model Number

84-10-2410

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

-

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

c3476e8f-2e1a-4dcd-b9fa-44ce31cace0f

Public Version Date

May 19, 2020

Public Version Number

2

DI Record Publish Date

October 25, 2019

Additional Identifiers

Package DI Number

00812231031995

Quantity per Package

1

Contains DI Package

00812231031896

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Loaner

"SANTA BARBARA IMAGING SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 36