Duns Number:107105876
Device Description: ACE HALO VEST SYSTEM UNIVERSAL TONG KIT
Catalog Number
1374
Brand Name
NA
Version/Model Number
1374
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 08, 2017
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
K954069
Product Code
HAX
Product Code Name
TONG, SKULL FOR TRACTION
Public Device Record Key
238dc7c6-cce7-486a-bf30-6fab54ab28b0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 30, 2016
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 | 5839 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2784 |
| U | Unclassified | 20 |