Duns Number:039576871
Device Description: LEKSELL KIT: 2103-39, 2103-26, 2103-58, 2103-59, 2103-62, 2103-61, 2103-76, 2103-77, FOR 3 LEKSELL KIT: 2103-39, 2103-26, 2103-58, 2103-59, 2103-62, 2103-61, 2103-76, 2103-77, FOR 3.2MM DRILL
Catalog Number
2103-07
Brand Name
PMT CORPORATION - STEREOTACTIC
Version/Model Number
2103-07
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
6ccd4a7a-4bb2-4674-ad36-7b7fd51c6868
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 15, 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 |