Duns Number:092364462
Catalog Number
-
Brand Name
TRA MEDICAL AND DENTAL SUPPLY
Version/Model Number
70226
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2019
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MCZ
Product Code Name
Suture removal kit
Public Device Record Key
7b655d01-0a5e-4c4b-9ac0-61fd9bf328aa
Public Version Date
October 01, 2019
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
20809160106508
Quantity per Package
50
Contains DI Package
10809160106501
Package Discontinue Date
September 30, 2019
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 548 |
2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
U | Unclassified | 1 |