20GA 45 Degree Pick - 297 Connector - 20GA 45° Pick - 297 Connector - PEREGRINE SURGICAL, LTD.

Duns Number:622467348

Device Description: 20GA 45° Pick - 297 Connector

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More Product Details

Catalog Number

-

Brand Name

20GA 45 Degree Pick - 297 Connector

Version/Model Number

PD102.04

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

K980797,K980797

Product Code Details

Product Code

MPA

Product Code Name

Endoilluminator

Device Record Status

Public Device Record Key

1a799ad9-0a92-4875-bd22-3b243fe1f1ba

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

May 06, 2016

Additional Identifiers

Package DI Number

10632307001175

Quantity per Package

5

Contains DI Package

00632307001178

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