Duns Number:070556204
Device Description: Curaplex EMS Shears, Pink, 7.25"
Catalog Number
2811-05529
Brand Name
Curaplex
Version/Model Number
2811-05529
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
-
Product Code
LRW
Product Code Name
SCISSORS, GENERAL, SURGICAL
Public Device Record Key
7ce0fd84-c4be-40bb-9c9a-ac179d082ada
Public Version Date
September 09, 2019
Public Version Number
1
DI Record Publish Date
August 30, 2019
Package DI Number
00812277035599
Quantity per Package
50
Contains DI Package
00812277035490
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |