Duns Number:039576871
Device Description: BRW/CRW KIT: 2103-26, 2103-33, 2103-40, 2103-45, 2103-47, 2103-51, FOR 3.2MM DRILL
Catalog Number
2103-83
Brand Name
PMT CORPORATION - STEREOTACTIC
Version/Model Number
2103-83
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
K831329
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
025492df-4452-4d66-9887-9817945174c8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 16, 2016
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 | 673 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8273 |
| U | Unclassified | 1188 |