Duns Number:070556204
Device Description: Curaplex TritonGrip SE Gloves, XL, Blue Nitrile, Powder Free 90/bx 10bx/cs
Catalog Number
1012-47126
Brand Name
Curaplex
Version/Model Number
1012-47126
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
1b5535ba-5240-4a54-aa07-4f93f3af2901
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
September 18, 2017
Package DI Number
00817617025520
Quantity per Package
10
Contains DI Package
00817617025346
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| 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 |