Duns Number:961027315
Device Description: VAGINAL SPECULUM ITEM # 14087
Catalog Number
NI16-1065
Brand Name
CARDINAL HEALTH
Version/Model Number
NI16-1065
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
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
a776c377-5d5f-4281-bc8b-821ed267a545
Public Version Date
October 22, 2018
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
50885425327049
Quantity per Package
20
Contains DI Package
10885425327041
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |