Duns Number:025460908
Device Description: SPECULUM,VAGINAL,MEDIUM,LGHT,NON-STERILE
Catalog Number
DYND70401M
Brand Name
Medline
Version/Model Number
DYND70401M
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
K050887,K050887
Product Code
HIB
Product Code Name
Speculum, vaginal, nonmetal
Public Device Record Key
7d365482-b68d-42ca-bf3e-b8ba0ea7cea6
Public Version Date
February 17, 2021
Public Version Number
3
DI Record Publish Date
October 14, 2016
Package DI Number
30080196806472
Quantity per Package
25
Contains DI Package
10080196806478
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |