Duns Number:789897865
Device Description: Rings Fixation Swivel FTR (Open Rings) - 13mm Bores
Catalog Number
25.268.1301
Brand Name
Mastel Precision Surgical Instruments, Inc.
Version/Model Number
25.268.1301
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
HMR
Product Code Name
Marker, Ocular
Public Device Record Key
ecd3a44c-1672-48d5-9653-db2fc0785c3e
Public Version Date
September 01, 2022
Public Version Number
1
DI Record Publish Date
August 24, 2022
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 | 274 |