Duns Number:039576871
Device Description: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 LARGE OPEN BACK RING, 1206-20 HEADBLOCKS, HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 LARGE OPEN BACK RING, 1206-20 HEADBLOCKS, 1206-11 TRACTION BAIL
Catalog Number
1217-160
Brand Name
PMT® Halo Systems
Version/Model Number
1217-160
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
5443e17b-aaf8-4e1f-b661-ffc76ddcb3cc
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 31, 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 |