Duns Number:835465063
Device Description: PACKING 8004009 NEURAY 200PK 76X76MM
Catalog Number
-
Brand Name
Neuray®
Version/Model Number
8004009
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
6be96ec8-da59-4588-8034-b09eaa25aa19
Public Version Date
March 25, 2019
Public Version Number
1
DI Record Publish Date
March 17, 2019
Package DI Number
20763000032863
Quantity per Package
200
Contains DI Package
00763000032869
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 |