Duns Number:005085972
Device Description: Micro Schlee Tissue Pliers Straight 18cm
Catalog Number
TPSLSSCHLE
Brand Name
HU-FRIEDY
Version/Model Number
TPSLSSCHLE
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFL
Product Code Name
FORCEPS, DRESSING, DENTAL
Public Device Record Key
f0ca9942-1f42-49fd-88a4-7c00d3d463ac
Public Version Date
August 24, 2020
Public Version Number
1
DI Record Publish Date
August 14, 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 | 7436 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |