Duns Number:007198742
Catalog Number
-
Brand Name
DISPOSABLE TYMPANOPLASTY BLADE STRAIGHT FOR USE W/130884 HANDLE STAIN
Version/Model Number
70130926
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRC
Product Code Name
INSTRUMENT, ENT MANUAL SURGICAL
Public Device Record Key
d4db9eb4-68ef-4e11-802f-41351f934b53
Public Version Date
June 08, 2021
Public Version Number
3
DI Record Publish Date
September 11, 2018
Package DI Number
00821925024885
Quantity per Package
6
Contains DI Package
00821925034976
Package Discontinue Date
-
Package Status
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 | 899 |
2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
3 | A medical device with high risk that requires premarket approval | 9 |
U | Unclassified | 4 |