PMT CORPORATION - STEREOTACTIC - STEALTH sEEG KIT: 2103-34 (QTY 2), 2103-52, - PMT CORPORATION

Duns Number:039576871

Device Description: STEALTH sEEG KIT: 2103-34 (QTY 2), 2103-52, 2103-92, 2103-60, 2103-68, 2103-69, 2103-71, 2 STEALTH sEEG KIT: 2103-34 (QTY 2), 2103-52, 2103-92, 2103-60, 2103-68, 2103-69, 2103-71, 2103-85, 2103-93, FOR 2.1MM DRILL

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More Product Details

Catalog Number

2103-50

Brand Name

PMT CORPORATION - STEREOTACTIC

Version/Model Number

2103-50

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Device Record Status

Public Device Record Key

eb247bd9-8d74-4c50-b780-bdd84a9fd512

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PMT CORPORATION" Characteristics
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