Duns Number:131855157
Device Description: Size: Pediatric; Color: Assorted.Contains two each of 50-402B & 50-402P.Contains one each Size: Pediatric; Color: Assorted.Contains two each of 50-402B & 50-402P.Contains one each of 50-402G & 50-402R.
Catalog Number
50-402A
Brand Name
Doyle Ear Dressing
Version/Model Number
50-402A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
NAD
Product Code Name
Dressing,Wound,Occlusive
Public Device Record Key
2a64b7c2-2146-4020-b731-90440870cbc1
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
34063107102197
Quantity per Package
6
Contains DI Package
14063107102193
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 121 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 211 |
| U | Unclassified | 1 |