Duns Number:096372255
Device Description: NEURO SPNG-1/2X3 in-STRL- 20/C TELFA
Catalog Number
30-057T
Brand Name
DeRoyal
Version/Model Number
30-057T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
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
EFQ
Product Code Name
GAUZE/SPONGE, INTERNAL
Public Device Record Key
de2958b0-30f7-4080-90d8-b66e7d1102c5
Public Version Date
August 13, 2021
Public Version Number
1
DI Record Publish Date
August 05, 2021
Package DI Number
30749756659599
Quantity per Package
20
Contains DI Package
00749756659598
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |