Catalog Number

8101

Brand Name

Instraspec

Version/Model Number

8101 Vaginal Speculum Medium

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

0089f42e-22f4-47fa-882b-cae749a54184

Public Version Date

July 18, 2022

Public Version Number

3

DI Record Publish Date

November 26, 2020

Package DI Number

05010058181014

Quantity per Package

25

Contains DI Package

05010058081017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box of 25