MST Subpial Transector - AD-TECH MEDICAL INSTRUMENT CORPORATION

Duns Number:174813410

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More Product Details

Catalog Number

MST-S03X

Brand Name

MST Subpial Transector

Version/Model Number

MST-S03X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

HAO

Product Code Name

INSTRUMENT, SURGICAL, NON-POWERED

Device Record Status

Public Device Record Key

d0242b20-4765-4bbd-96e0-4fcd74fdbf4b

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

90841823107063

Quantity per Package

3

Contains DI Package

00841823107060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"AD-TECH MEDICAL INSTRUMENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 796