Kit Rinse Manifold, Packaged - Bulk ACL TOP System Rinse Manifold - INSTRUMENTATION LABORATORY COMPANY

Duns Number:557223252

Device Description: Bulk ACL TOP System Rinse Manifold

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More Product Details

Catalog Number

00000011857

Brand Name

Kit Rinse Manifold, Packaged

Version/Model Number

00000011857

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)

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

eae5a7c3-a8a7-4890-be0e-7f42a84afb87

Public Version Date

July 13, 2021

Public Version Number

4

DI Record Publish Date

June 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSTRUMENTATION LABORATORY COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 272