Duns Number:210164398
Catalog Number
-
Brand Name
2.5mm Mid-Reach Retinal Pencil
Version/Model Number
2509-P-8002
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062412
Product Code
HRN
Product Code Name
Unit, Cryophthalmic, Ac-Powered
Public Device Record Key
13a77c74-7c1b-4c98-8dfe-cf74db8c0448
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 16, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 158 |