Duns Number:097824130
Catalog Number
DFH-0030
Brand Name
Seibel Capsulorhexis Forceps with Rhexis Ruler and View Port, Sharp
Version/Model Number
DFH-0030
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
-
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
HNR
Product Code Name
Forceps, Ophthalmic
Public Device Record Key
f15355b7-9b06-4ef0-be42-b7ebc679ff67
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
September 18, 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 | 327 |
2 | A medical device with a moderate to high risk that requires special controls. | 535 |