Duns Number:763408366
Device Description: A hand-held manual ophthalmic surgical instrument with small blades designed to grasp and A hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.
Catalog Number
-
Brand Name
WATZKE FORCEPS
Version/Model Number
S5.3100
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
5dac48d4-c877-4b59-bbd3-8e213a37c2e0
Public Version Date
June 07, 2021
Public Version Number
1
DI Record Publish Date
May 30, 2021
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 291 |
| U | Unclassified | 60 |