Duns Number:013469890
Device Description: Bulk Packaged Ultra Premium PVA Spear. Our effective synthetic PVA sponges and fluid manag Bulk Packaged Ultra Premium PVA Spear. Our effective synthetic PVA sponges and fluid management items are highly absorbent allowing aqueous solutions to be wicked up quickly. Our ULTRA PREMIUM Spears are 100% lint free. Bag of five pcs per foil 100 foils per bag.
Catalog Number
MK-108B
Brand Name
PRO-PAKS®️
Version/Model Number
MK-108B
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
decb729d-b014-4332-bc09-4aebd3869b12
Public Version Date
November 30, 2018
Public Version Number
1
DI Record Publish Date
October 30, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |