Duns Number:809555139
Device Description: Utrata Capsulorrhexis Forceps, Very Delicate, Angled 11mm from bend to tip with extremely Utrata Capsulorrhexis Forceps, Very Delicate, Angled 11mm from bend to tip with extremely thin triangular grasping tips, Straight knurled handle, Guide pin stop for tip alignment, 105mm total length, Titanium
Catalog Number
F610T-A
Brand Name
Diamatrix
Version/Model Number
F610T-A
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
HNR
Product Code Name
Forceps, Ophthalmic
Public Device Record Key
593924d8-0ed6-4196-bd97-903ab4344fb4
Public Version Date
October 14, 2020
Public Version Number
1
DI Record Publish Date
October 06, 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 | 475 |
U | Unclassified | 13 |