SILICONE MAT - SILICONE MAT FOR UPPER TRAY - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: SILICONE MAT FOR UPPER TRAY

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More Product Details

Catalog Number

18-3241M

Brand Name

SILICONE MAT

Version/Model Number

18-3241M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 22, 2021

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

-

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

LRP

Product Code Name

TRAY, SURGICAL

Device Record Status

Public Device Record Key

e40ed244-f24e-43f9-a15c-687857ecd5fe

Public Version Date

September 16, 2022

Public Version Number

7

DI Record Publish Date

September 17, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414