Duns Number:013469890
Device Description: Drape Ophthalmic, 3-sided Gutter Pouch, Incise, Non-woven with Plastic head. Made from hi Drape Ophthalmic, 3-sided Gutter Pouch, Incise, Non-woven with Plastic head. Made from high quality fabric and finishes providing our customers with an enhanced experience while using our drapes. 10 per bag.
Catalog Number
PD117
Brand Name
PRO-PAKS®️
Version/Model Number
PD117
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
82162645-a28b-4302-bbb6-1644a6c031cf
Public Version Date
November 30, 2018
Public Version Number
1
DI Record Publish Date
October 30, 2018
Package DI Number
30810003220234
Quantity per Package
10
Contains DI Package
10810003220230
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 | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 5 |