Duns Number:093377724
Device Description: Each kit contains one 9101 Instrument Wipe, one 9802 Fluid Wick, one 9202 Corneal Light Sh Each kit contains one 9101 Instrument Wipe, one 9802 Fluid Wick, one 9202 Corneal Light Shield, all used for fluid absorption during eye surgery.
Catalog Number
9803
Brand Name
Absorbent Kit
Version/Model Number
9803
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
K990671,K990671
Product Code
HOZ
Product Code Name
Sponge, Ophthalmic
Public Device Record Key
5db47230-05c2-47ec-be5f-31bee32778b3
Public Version Date
April 10, 2020
Public Version Number
5
DI Record Publish Date
February 16, 2017
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 | 75 |