Duns Number:008018525
Device Description: Eye Pak* 1021 Plastic Ophthalmic Drape APERTURE
Catalog Number
-
Brand Name
Alcon Eye-Pak
Version/Model Number
8065102120
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
HMT
Product Code Name
Drape, patient, ophthalmic
Public Device Record Key
95b12503-ca38-40c3-a784-9767afb6eac3
Public Version Date
January 24, 2022
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
10380651021201
Quantity per Package
10
Contains DI Package
00380651021204
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |