Duns Number:093377724
Device Description: Surgical Spears are used during ophthalmic surgical procedures to manipulate eye tissue an Surgical Spears are used during ophthalmic surgical procedures to manipulate eye tissue and remove debris and fluid from the surgical site
Catalog Number
9001
Brand Name
Surgical Spears
Version/Model Number
9001
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
7308a651-f2c8-4474-ab59-530d1d6c0857
Public Version Date
April 14, 2020
Public Version Number
3
DI Record Publish Date
May 22, 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 | 75 |