Catalog Number

-

Brand Name

Castroviejo Caliper

Version/Model Number

12-9300D

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

-

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

HOE

Product Code Name

Caliper, ophthalmic

Public Device Record Key

7e512c59-a45a-4bff-91a8-39631d7e479a

Public Version Date

December 06, 2021

Public Version Number

1

DI Record Publish Date

November 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-