Catalog Number

C020120-1

Brand Name

ER-SPEC/OFFICESPEC

Version/Model Number

C020120-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

K091937,K091937,K091937

Product Code

HIB

Product Code Name

Speculum, Vaginal, Nonmetal

Public Device Record Key

73508efb-e5bd-4f1f-aacd-1a1078e36bcc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

M648C02012012

Quantity per Package

4

Contains DI Package

M648C02012011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE