NA - EM XM Cleaning and Sterilization Basket - Insert - Anspach Effort, The

Duns Number:079116867

Device Description: EM XM Cleaning and Sterilization Basket - Insert

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More Product Details

Catalog Number

EX-BSKT-INS

Brand Name

NA

Version/Model Number

EX-BSKT-INS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 18, 2022

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)

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

LRP

Product Code Name

TRAY, SURGICAL

Device Record Status

Public Device Record Key

bc2aa64b-31a7-4064-8729-cce43a7d8c08

Public Version Date

March 18, 2022

Public Version Number

4

DI Record Publish Date

February 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANSPACH EFFORT, THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 294
2 A medical device with a moderate to high risk that requires special controls. 910