PCL-PLUG 2MM X 0.4MM - PCL-PLUG 2MM X 0.4MM - Surgical Specialties México, S. de R.L. de C.V.

Duns Number:812762226

Device Description: PCL-PLUG 2MM X 0.4MM

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More Product Details

Catalog Number

-

Brand Name

PCL-PLUG 2MM X 0.4MM

Version/Model Number

EPLUG4

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

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

LZU

Product Code Name

Plug, punctum

Device Record Status

Public Device Record Key

3ef40f88-6fd3-4d28-b6d7-77549ed5a1bc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

10848782023827

Quantity per Package

10

Contains DI Package

00848782023820

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 300
2 A medical device with a moderate to high risk that requires special controls. 2030
U Unclassified 19