Duns Number:832637081
Device Description: 2.0MM OLIVE WIRE 10MM TROCAR TIP
Catalog Number
SD03212110
Brand Name
NA
Version/Model Number
SD03.212.110
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
-
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
HWN
Product Code Name
INSTRUMENT, COMPRESSION
Public Device Record Key
31cc58a5-f967-4ea3-8aea-c45c595ca550
Public Version Date
August 08, 2022
Public Version Number
1
DI Record Publish Date
July 29, 2022
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 | 1194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
| 3 | A medical device with high risk that requires premarket approval | 30 |
| U | Unclassified | 1 |