Small T-Scan Evolution Sensors (Box of 20) - Small T-Scan Evolution Sensors (20 per Box) - Tekscan, Inc.

Duns Number:178180246

Device Description: Small T-Scan Evolution Sensors (20 per Box)

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More Product Details

Catalog Number

2501-BOX20

Brand Name

Small T-Scan Evolution Sensors (Box of 20)

Version/Model Number

Small T-Scan Evolution Sensors (Box of 20)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

EFH

Product Code Name

Paper, Articulation

Device Record Status

Public Device Record Key

5fd69be7-e5ad-4cac-a67d-0e77b63268ba

Public Version Date

November 11, 2020

Public Version Number

1

DI Record Publish Date

November 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEKSCAN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 199