Duns Number:079840876
Device Description: Inline Cupped Compressor
Catalog Number
SR-0206
Brand Name
General Instrument
Version/Model Number
SR-0206
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
HWN
Product Code Name
INSTRUMENT, COMPRESSION
Public Device Record Key
a66ce211-33f0-4ce9-8daf-c914411652f1
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 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 | 5602 |
2 | A medical device with a moderate to high risk that requires special controls. | 14020 |
U | Unclassified | 21 |