22 MM SMOOTHBORE DUAL LIMB TUBE CLIP - 22 MM SMOOTHBORE DUAL LIMB TUBE CLIP - Intersurgical Incorporated

Duns Number:785952607

Device Description: 22 MM SMOOTHBORE DUAL LIMB TUBE CLIP

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More Product Details

Catalog Number

-

Brand Name

22 MM SMOOTHBORE DUAL LIMB TUBE CLIP

Version/Model Number

2314000

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"

Yes

For Single-Use

-

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

d27f9c18-4710-44a7-8536-12bb9988933e

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 14, 2021

Additional Identifiers

Package DI Number

05030267093274

Quantity per Package

100

Contains DI Package

05030267091393

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