Duns Number:039576871
Device Description: BRAINLAB sEEG KIT: 2103-34 (QTY 2), 2103-52, 2103-60, 2103-64, 2103-68, 2103-69, 2103-85, BRAINLAB sEEG KIT: 2103-34 (QTY 2), 2103-52, 2103-60, 2103-64, 2103-68, 2103-69, 2103-85, 2103-92, 2103-93, FOR 2.1MM DRILL
Catalog Number
2103-22
Brand Name
PMT CORPORATION - STEREOTACTIC
Version/Model Number
2103-22
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
b8421db2-3708-4b4f-8ed9-c82f26b50ee5
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 |