Duns Number:832696038
Device Description: CASTROVIEJO EYE SPECULUM OPEN BLADES 15 X 7.5MM WIDE CURVED ARMS OVERALL LENGTH 3-1/4"(8.3 CASTROVIEJO EYE SPECULUM OPEN BLADES 15 X 7.5MM WIDE CURVED ARMS OVERALL LENGTH 3-1/4"(8.3CM)
Catalog Number
OP70
Brand Name
V. Mueller
Version/Model Number
OP70
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
HNC
Product Code Name
Specula, ophthalmic
Public Device Record Key
07ea8afd-ddf3-4e2e-a4aa-d43077e7b0e2
Public Version Date
October 08, 2018
Public Version Number
1
DI Record Publish Date
September 07, 2018
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 |