Duns Number:006261481
Device Description: COMPRESSION DEVICE TRACR TRACELET 5PK GL
Catalog Number
-
Brand Name
TRAcelet™
Version/Model Number
TRACR
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162027,K162027
Product Code
DXC
Product Code Name
CLAMP, VASCULAR
Public Device Record Key
60da22f8-b166-41f4-be04-f18735312827
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 15, 2017
Package DI Number
20643169900909
Quantity per Package
5
Contains DI Package
00643169900905
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 | 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 |