Dale Adhesive Base - Dale Adhesive Base for Dale 270 and 280 - DALE MEDICAL PRODUCTS, INC.

Duns Number:001061233

Device Description: Dale Adhesive Base for Dale 270 and 280

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More Product Details

Catalog Number

273

Brand Name

Dale Adhesive Base

Version/Model Number

273

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CBH

Product Code Name

Device, Fixation, Tracheal Tube

Device Record Status

Public Device Record Key

19cda653-b418-4041-b67f-56a3b9bcd0c5

Public Version Date

November 27, 2019

Public Version Number

2

DI Record Publish Date

August 29, 2018

Additional Identifiers

Package DI Number

H84102732

Quantity per Package

10

Contains DI Package

H84102731

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"DALE 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 74
2 A medical device with a moderate to high risk that requires special controls. 2