Duns Number:129278169
Catalog Number
821062000
Brand Name
TREPHINE
Version/Model Number
8210-62-000
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
cb243b96-9834-4db9-a940-526a81344d74
Public Version Date
June 01, 2020
Public Version Number
1
DI Record Publish Date
May 23, 2020
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 | 11962 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28376 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |