Duns Number:801895244
Device Description: Galenica 1 Large Vaginal Speculum
Catalog Number
-
Brand Name
Galenica
Version/Model Number
8617
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K841909,K841909,K841909
Product Code
HIB
Product Code Name
Speculum, Vaginal, Nonmetal
Public Device Record Key
bc1c4487-0246-4ae4-93a2-3f36456c6a37
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
40888937012437
Quantity per Package
24
Contains DI Package
20888937012433
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |