Duns Number:071595540
Device Description: DIGIT TRAP FINGER GRASPING DEVICE
Catalog Number
9906
Brand Name
DIGIT TRAP
Version/Model Number
9906
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HST
Product Code Name
Apparatus, traction, non-powered
Public Device Record Key
afa1e854-0fa5-48da-8937-067cd5477763
Public Version Date
October 19, 2021
Public Version Number
1
DI Record Publish Date
October 11, 2021
Package DI Number
20845854013226
Quantity per Package
1
Contains DI Package
10845854013229
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |