Duns Number:832696038
Device Description: SKEELE CHALAZION CURETTE SERRATED CUP, DIAMETER 2MM OVERALL LENGTH 5" (12.7CM)
Catalog Number
OP1790
Brand Name
V. Mueller
Version/Model Number
OP1790
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
-
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
HNZ
Product Code Name
Curette, ophthalmic
Public Device Record Key
b9825c24-c0c3-4901-a685-bdfe8a6e653a
Public Version Date
April 23, 2020
Public Version Number
1
DI Record Publish Date
April 15, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |