APEX - DOUBLE CEILING MOUNT (10FT.) - BURTON MEDICAL PRODUCTS CORPORATION

Duns Number:022382667

Device Description: DOUBLE CEILING MOUNT (10FT.)

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More Product Details

Catalog Number

6000214-2

Brand Name

APEX

Version/Model Number

APXDC10

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K963682

Product Code Details

Product Code

FSY

Product Code Name

Light, Surgical, Ceiling Mounted

Device Record Status

Public Device Record Key

d933861a-8c9b-4d63-afd3-95482338c6be

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

June 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BURTON MEDICAL PRODUCTS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22