Duns Number:039576871
Device Description: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1201-1 XX-LARGE CLOSED BACK RING, 1206-25 HEADBL HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1201-1 XX-LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS, W/ NO TRACTION BAIL
Catalog Number
1218-072
Brand Name
PMT® Halo Systems
Version/Model Number
1218-072
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
K090733
Product Code
HAX
Product Code Name
Tong, Skull For Traction
Public Device Record Key
0948cc75-fb62-4c4c-b59c-d5f151f67f69
Public Version Date
July 23, 2018
Public Version Number
1
DI Record Publish Date
June 20, 2018
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 | 673 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8273 |
| U | Unclassified | 1188 |