Duns Number:039576871
Device Description: DEPTH STOP FOR 2.4MM DRILL FOR SEEG ANCHOR BOLT, TO BE USED WITH MODEL 2103-190 ALLEN WREN DEPTH STOP FOR 2.4MM DRILL FOR SEEG ANCHOR BOLT, TO BE USED WITH MODEL 2103-190 ALLEN WRENCH
Catalog Number
-
Brand Name
PMT CORPORATION - STEREOTACTIC
Version/Model Number
2103-188
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
Yes
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
1fcd98b3-26af-4461-94d1-fb5fd7775f26
Public Version Date
July 20, 2021
Public Version Number
1
DI Record Publish Date
July 12, 2021
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 |