Duns Number:070556204
Device Description: SHEARS, CURAPLEX PARAMEDIC, 7.5" BLUE
Catalog Number
2811-05532
Brand Name
CURAPLEX
Version/Model Number
2811-05532
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
b2b465f8-cf2f-4a93-ac78-e939e8744b18
Public Version Date
April 09, 2021
Public Version Number
1
DI Record Publish Date
April 01, 2021
Package DI Number
00810071631528
Quantity per Package
200
Contains DI Package
00810071631511
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 | 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 |