Devon - 7700-EDn Surgical Set Up Kit - Cardinal Health, Inc.

Duns Number:080935429

Device Description: 7700-EDn Surgical Set Up Kit

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More Product Details

Catalog Number

31153714

Brand Name

Devon

Version/Model Number

31153714

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

281095ae-3aed-4c30-a0a7-c4aab985721f

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

June 27, 2018

Additional Identifiers

Package DI Number

10884527013982

Quantity per Package

8

Contains DI Package

20884527013989

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17