Duns Number:081853285
Device Description: Shepard-Hoffer O/Z Marker With Cross Hair, 8.0mm
Catalog Number
S9-1064
Brand Name
Stephens Instruments
Version/Model Number
S9-1064
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
-
Product Code
HMQ
Product Code Name
Marker, sclera
Public Device Record Key
5b5ec80b-50a1-41ad-9d39-f8a5e079e3dd
Public Version Date
September 30, 2020
Public Version Number
1
DI Record Publish Date
September 22, 2020
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 | 995 |
U | Unclassified | 24 |