Tarry Temperature Probe Cover - Hydrogel probe cover, Silver Hearts, Large, (1 - TARRY MEDICAL PRODUCTS, INC.

Duns Number:107260002

Device Description: Hydrogel probe cover, Silver Hearts, Large, (1 1/4")

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More Product Details

Catalog Number

T 80450 B100

Brand Name

Tarry Temperature Probe Cover

Version/Model Number

T 80450

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

4a701cf4-7b1d-40b3-834c-4e351b3f897f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TARRY MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 9