Duns Number:130785884
Device Description: Disposable Easy Catcher
Catalog Number
-
Brand Name
Easy Catcher
Version/Model Number
O-EC52-JP
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012168,K012168
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
eba193ee-be47-4d1a-9fae-fb1b99ac0afc
Public Version Date
May 24, 2022
Public Version Number
1
DI Record Publish Date
May 16, 2022
Package DI Number
10848340016599
Quantity per Package
10
Contains DI Package
00848340016592
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 619 |
| U | Unclassified | 3 |