Duns Number:961027315
Device Description: Ophthalmic Incise Sheet
Catalog Number
D1165
Brand Name
CONVERTORS
Version/Model Number
D1165
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 06, 2021
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HMT
Product Code Name
Drape, patient, ophthalmic
Public Device Record Key
491ff3ae-68f6-4a2e-a846-fd93ae5b7aac
Public Version Date
August 06, 2021
Public Version Number
5
DI Record Publish Date
September 11, 2017
Package DI Number
50885380146051
Quantity per Package
20
Contains DI Package
10885380146053
Package Discontinue Date
August 06, 2021
Package Status
Not in Commercial Distribution
Package Type
EACH
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |