Duns Number:763408366
Device Description: A collection of various ophthalmic surgical instruments and the necessary materials intend A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. This is a single-use device.
Catalog Number
S5.7020U
Brand Name
Ophthalmic surgical procedure kit, non-medicated, single-use
Version/Model Number
SELF-BLOCKING VITRECTOMY INFUSION AND CANNULA SET
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
Yes
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
HJK
Product Code Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Public Device Record Key
54efba00-d08f-4e75-a8ac-6edf919ed0ef
Public Version Date
March 16, 2020
Public Version Number
1
DI Record Publish Date
March 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 291 |
| U | Unclassified | 60 |