Duns Number:942667882
Device Description: Speculum, Rectal Bulb Style Large Speculum Kit ~ 3/8 inflow hose ~ 48 waste hose ~ G-Hose Speculum, Rectal Bulb Style Large Speculum Kit ~ 3/8 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 924648 (Class I Device)
Catalog Number
924648
Brand Name
Speculum, Rectal Kit
Version/Model Number
SPO1 Large Bulb 3848 G-Hose
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FFQ
Product Code Name
Speculum, Rectal
Public Device Record Key
1a09e337-ea62-4b17-8250-ec1fc6d5f096
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
September 05, 2017
Package DI Number
B4249246480
Quantity per Package
1
Contains DI Package
B424924648
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Plastic Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |