SUPERSET ELBOW 22M/15F, 15M, LUER + CAP - SUPERSET ELBOW 22M/15F, 15M, LUER + CAP - Intersurgical Incorporated

Duns Number:785952607

Device Description: SUPERSET ELBOW 22M/15F, 15M, LUER + CAP

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More Product Details

Catalog Number

-

Brand Name

SUPERSET ELBOW 22M/15F, 15M, LUER + CAP

Version/Model Number

1993001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

BZA

Product Code Name

Connector, Airway (Extension)

Device Record Status

Public Device Record Key

7d484c32-9aaf-4300-b102-dec69f415765

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 14, 2021

Additional Identifiers

Package DI Number

05030267088904

Quantity per Package

400

Contains DI Package

05030267058037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INTERSURGICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 101