Duns Number:796986144
Device Description: HEADREST PH-2500 PASSIVE NEXFR GLBL MKT
Catalog Number
-
Brand Name
NA
Version/Model Number
PH-2500
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
-
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
K031885
Product Code
HBL
Product Code Name
HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
Public Device Record Key
bfb9cd88-9d7f-423f-a8f5-d02bc67bb91b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 18, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |