Duns Number:070556204
Device Description: Curaplex Lubricating Jelly, Foil Packet 2.7g
Catalog Number
1340-27000
Brand Name
Curaplex
Version/Model Number
1340-27000
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMJ
Product Code Name
Lubricant, patient
Public Device Record Key
189e38d3-7f66-4278-8191-a8b299a0bc3c
Public Version Date
January 15, 2019
Public Version Number
1
DI Record Publish Date
December 15, 2018
Package DI Number
00812277031386
Quantity per Package
144
Contains DI Package
00812277031379
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |