Duns Number:198227881
Device Description: Cervical Model for Video Colposcope
Catalog Number
88010
Brand Name
Welch Allyn, Inc.
Version/Model Number
901073
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2019
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
-
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
K955635
Product Code
HEX
Product Code Name
COLPOSCOPE (AND COLPOMICROSCOPE)
Public Device Record Key
0f5bdf32-2360-473a-ac65-af6c01d06d91
Public Version Date
October 01, 2019
Public Version Number
5
DI Record Publish Date
September 17, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |