STARLED3 NX - STARLED3 NX 1-ARM CEILING STANDARD LINE - ACEM SPA

Duns Number:435188508

Device Description: STARLED3 NX 1-ARM CEILING STANDARD LINE

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More Product Details

Catalog Number

110605

Brand Name

STARLED3 NX

Version/Model Number

STARLED3 NX /SC1

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)

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

FSY

Product Code Name

Light, Surgical, Ceiling Mounted

Device Record Status

Public Device Record Key

43533e7b-7c0b-4981-8ac8-6aa0e99c9c22

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

January 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACEM SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 41
2 A medical device with a moderate to high risk that requires special controls. 18