Duns Number:025460908
Device Description: 2053 @ECTR, PUSH BLADE
Catalog Number
2053R
Brand Name
Medline
Version/Model Number
2053R
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
GES
Product Code Name
BLADE, SCALPEL
Public Device Record Key
d8ead2ed-0166-4f48-b1f4-fa2787752e3e
Public Version Date
May 20, 2022
Public Version Number
1
DI Record Publish Date
May 12, 2022
Package DI Number
20888277372624
Quantity per Package
6
Contains DI Package
10888277372627
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |