Duns Number:315018218
Device Description: TISSUE PROTECTOR SHEATHF/3.5MM DIA TAPS
Catalog Number
LS071S
Brand Name
AESCULAP
Version/Model Number
LS071S
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
HXX
Product Code Name
SCREWDRIVER
Public Device Record Key
dae1f37d-7303-4063-9a35-0d66015148e8
Public Version Date
July 20, 2021
Public Version Number
2
DI Record Publish Date
April 21, 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 | 11840 |
2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
3 | A medical device with high risk that requires premarket approval | 37 |