Duns Number:239505063
Device Description: Micro Ear Forceps 3mm Micro Ear Forceps 3mm
Catalog Number
S221
Brand Name
Single Use Surgical Professional
Version/Model Number
S221
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KAE
Product Code Name
Forceps, Ent
Public Device Record Key
c5f71931-e592-4dfc-bce8-8f01fdbda7b9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 09, 2016
Package DI Number
05055299103630
Quantity per Package
25
Contains DI Package
05055299103265
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |