Duns Number:264255288
Device Description: AIRLOCK Single-Use MTP Reamer 20mm
Catalog Number
SUI04020
Brand Name
Airlock
Version/Model Number
SUI04020
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
HWE
Product Code Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Public Device Record Key
0bf24ba5-1d56-4a65-9667-02dda7826f97
Public Version Date
December 13, 2019
Public Version Number
1
DI Record Publish Date
December 05, 2019
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 | 289 |
2 | A medical device with a moderate to high risk that requires special controls. | 494 |