ACC. PROBE, ENDO.ST ILLUMINA 20G, - ELLEX MEDICAL PTY LTD

Duns Number:756138509

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More Product Details

Catalog Number

ENDOPROBE ST ILLUMINA 20G,

Brand Name

ACC. PROBE, ENDO.ST ILLUMINA 20G,

Version/Model Number

A527100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K050807,K050807

Product Code Details

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Device Record Status

Public Device Record Key

17f2ba39-0484-44d9-a5b7-b14e46c3e277

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 21, 2017

Additional Identifiers

Package DI Number

09342395000779

Quantity per Package

10

Contains DI Package

09342395002001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"ELLEX MEDICAL PTY LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 62