Duns Number:013469890
Device Description: Premium PVA Spear. Our effective synthetic PVA sponges and fluid management items are high Premium PVA Spear. Our effective synthetic PVA sponges and fluid management items are highly absorbent allowing aqueous solutions to be wicked up quickly. 15 per box with 10 pieces each.
Catalog Number
MK-103
Brand Name
PRO-PAKS®️
Version/Model Number
MK-103
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
HOZ
Product Code Name
Sponge, Ophthalmic
Public Device Record Key
404bbfab-c7cf-4a40-a9c5-cc3f50c1fbc6
Public Version Date
November 30, 2018
Public Version Number
1
DI Record Publish Date
October 30, 2018
Package DI Number
30810003220012
Quantity per Package
15
Contains DI Package
10810003220018
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 |