PALA-NATE - PALATE GUARD, Palate Protection for Neonates, - UTAH MEDICAL PRODUCTS, INC.

Duns Number:094651270

Device Description: PALATE GUARD, Palate Protection for Neonates, 2.0cm X 1.8cm, Small

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More Product Details

Catalog Number

4002000

Brand Name

PALA-NATE

Version/Model Number

Small

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"

Yes

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

K923591,K923591

Product Code Details

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Device Record Status

Public Device Record Key

1c7f61b0-5712-48fb-be99-76f4a717bf9f

Public Version Date

December 18, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

H67140020001

Quantity per Package

10

Contains DI Package

H67140020000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"UTAH 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 35
2 A medical device with a moderate to high risk that requires special controls. 274