HMR-550 - Reusable Surgical Laser Fiber 550/608/780, - INTERNATIONAL MEDICAL LASERS, INC.

Duns Number:078534357

Device Description: Reusable Surgical Laser Fiber 550/608/780, silicone, blue tefzel, NA 0.22, damage resistan Reusable Surgical Laser Fiber 550/608/780, silicone, blue tefzel, NA 0.22, damage resistant SMA905, reusable, blue extension sleeves with logo, EO sterile, Flat Tip, IML label

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More Product Details

Catalog Number

-

Brand Name

HMR-550

Version/Model Number

HMR-550

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)

Yes

FDA Premarket Submission

-

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

aedc09fa-bfb5-4577-9efc-903b1451fdf5

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

August 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTERNATIONAL MEDICAL LASERS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19