Duns Number:961027315
Device Description: Ophthalmic Drape
Catalog Number
7445
Brand Name
CONVERTORS
Version/Model Number
7445
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 12, 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
229185cf-b4d3-48d5-91b5-5747e26df951
Public Version Date
August 13, 2021
Public Version Number
3
DI Record Publish Date
July 13, 2018
Package DI Number
50885380122406
Quantity per Package
10
Contains DI Package
10885380122408
Package Discontinue Date
August 12, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| 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 |