Duns Number:784259751
Device Description: IMPACT 20MMX2CMX75CM
Catalog Number
202750
Brand Name
Impact™
Version/Model Number
202750
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"
Yes
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
KNQ
Product Code Name
Dilator, esophageal
Public Device Record Key
300ab9a9-cb66-4b2e-a6c9-e6765145b677
Public Version Date
October 18, 2021
Public Version Number
5
DI Record Publish Date
August 09, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1226 |
3 | A medical device with high risk that requires premarket approval | 361 |