Duns Number:316803246
Device Description: Sugi iSpear (pointed tip), round light blue handle non-sterile,500 x 10 pcs.
Catalog Number
30671
Brand Name
Sugi
Version/Model Number
30671
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 06, 2022
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
840913a0-d8b6-46fd-a673-165b0441d10d
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
September 06, 2019
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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 248 |