UltraSlim Digital - UltraSlim Digital, Red Light (635nm) - WARD PHOTONICS LLC

Duns Number:090686710

Device Description: UltraSlim Digital, Red Light (635nm)

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More Product Details

Catalog Number

60008

Brand Name

UltraSlim Digital

Version/Model Number

60008

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

K202361

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

d2325978-8e6b-41ff-bbe5-201c8d33cb67

Public Version Date

January 12, 2021

Public Version Number

1

DI Record Publish Date

January 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WARD PHOTONICS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4