Catalog Number

0502-548-010

Brand Name

SPY

Version/Model Number

0502548010

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

-

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

K221217

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

e77b17a6-32e8-4706-a9e5-c21465ea14bd

Public Version Date

September 07, 2022

Public Version Number

2

DI Record Publish Date

August 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-