20GA Hard Tip Aspirating Laser Probe - Alcon - 20GA Hard Tip Aspirating Laser Probe - Alcon - PEREGRINE SURGICAL, LTD.

Duns Number:622467348

Device Description: 20GA Hard Tip Aspirating Laser Probe - Alcon

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More Product Details

Catalog Number

-

Brand Name

20GA Hard Tip Aspirating Laser Probe - Alcon

Version/Model Number

PD720.60HT

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"

Yes

For Single-Use

Yes

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

K061024,K061024

Product Code Details

Product Code

HQE

Product Code Name

INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Device Record Status

Public Device Record Key

1823e5e3-0920-45ca-8fd0-5076e0ce7ed6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 06, 2016

Additional Identifiers

Package DI Number

10632307000284

Quantity per Package

5

Contains DI Package

00632307000287

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"PEREGRINE SURGICAL, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 177