Catalog Number

7-56443

Brand Name

CareSpec

Version/Model Number

7-56443

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HIB

Product Code Name

Speculum, Vaginal, Nonmetal

Public Device Record Key

2129b2ee-3a54-429a-94c7-055e68f19922

Public Version Date

April 02, 2018

Public Version Number

1

DI Record Publish Date

March 01, 2018

Package DI Number

20816908010720

Quantity per Package

4

Contains DI Package

10816908010723

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case