Duns Number:835465063
Device Description: PACKING 8003099 NEURAY 200PK 7X7MM
Catalog Number
-
Brand Name
NEURAY ®
Version/Model Number
8003099
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
K923027,K923027
Product Code
HBA
Product Code Name
NEUROSURGICAL PADDIE
Public Device Record Key
98e1efd3-d9d2-4ea6-8684-86d1c8493a10
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2017
Package DI Number
20643169931972
Quantity per Package
200
Contains DI Package
00643169931978
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 665 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
| 3 | A medical device with high risk that requires premarket approval | 6 |
| U | Unclassified | 10 |