25GA Curved Illuminating Laser Probe - Short - 25GA Curved Illuminating Laser Probe - Short - PEREGRINE SURGICAL, LTD.

Duns Number:622467348

Device Description: 25GA Curved Illuminating Laser Probe - Short

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More Product Details

Catalog Number

-

Brand Name

25GA Curved Illuminating Laser Probe - Short

Version/Model Number

PD725.37SDD

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

-

Product Code Details

Product Code

HQB

Product Code Name

Photocoagulator And Accessories

Device Record Status

Public Device Record Key

583fbfc5-7a2e-4173-b37d-fd87ce01d795

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 13, 2017

Additional Identifiers

Package DI Number

10632307002196

Quantity per Package

6

Contains DI Package

00632307002199

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