Lac-Mac - Extra Large Back Table Cover, 94 X 58, LML - Lac-Mac Limited

Duns Number:201276334

Device Description: Extra Large Back Table Cover, 94 X 58, LML Barcode, Barrier 82X27

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More Product Details

Catalog Number

025ZS

Brand Name

Lac-Mac

Version/Model Number

025ZS

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K031362

Product Code Details

Product Code

KKX

Product Code Name

Drape, Surgical

Device Record Status

Public Device Record Key

8c5540d8-c411-4c7a-a92e-2a42a2d9cb25

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

May 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LAC-MAC LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 216