Duns Number:011560431
Device Description: 90mm x 18mm SINGLE-USE SLOTTED ANOSCOPE WITH BUILT-IN LIGHT SOURCE
Catalog Number
C060100
Brand Name
ANOSPEC
Version/Model Number
C060100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K121604,K121604,K121604
Product Code
FER
Product Code Name
Anoscope And Accessories
Public Device Record Key
5bfebf99-40d4-45e9-a912-6a86b3aea265
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
M648C0601002
Quantity per Package
4
Contains DI Package
M648C0601001
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |