Duns Number:040729840
Device Description: CONVERSE HAND RETRACTOR WITH FIBER OPTIC LIGHT GUIDE DOUBLE ENDED STRAIGHT/CURVED BLADES # CONVERSE HAND RETRACTOR WITH FIBER OPTIC LIGHT GUIDE DOUBLE ENDED STRAIGHT/CURVED BLADES #4
Catalog Number
205-910L
Brand Name
CONVERSE HAND RETRACTOR
Version/Model Number
205-910L
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FDG
Product Code Name
RETRACTOR, FIBEROPTIC
Public Device Record Key
881da071-c920-4b3f-9f54-2bd8a9db508b
Public Version Date
October 19, 2018
Public Version Number
1
DI Record Publish Date
September 18, 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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |