Duns Number:001137280
Device Description: Neutec® Neurological Pattie • 1/2 X 1 Rayon, X-Ray Detectable
Catalog Number
35501310
Brand Name
FABCO
Version/Model Number
35501310
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"
-
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
9da2a2d0-9e1d-4de7-9349-0ffd35231f82
Public Version Date
January 31, 2019
Public Version Number
1
DI Record Publish Date
December 31, 2018
Package DI Number
50634303550044
Quantity per Package
20
Contains DI Package
30634303550040
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Dispenser Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |