Duns Number:002112626
Device Description: Pediatric Anal Dilator, 8mm Size, Single Patient-Multiple Use, Non-Sterile
Catalog Number
PAD08
Brand Name
Pediatric Anal Dilator
Version/Model Number
PAD08
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
-
Product Code
FFP
Product Code Name
Dilator, Rectal
Public Device Record Key
958855a8-1b12-44fa-abb1-8c2c42567b7f
Public Version Date
August 03, 2022
Public Version Number
2
DI Record Publish Date
July 18, 2022
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 436 |