IV3000 7X9CM NON STERILE NO POUCH - IV3000 Bulk Non Sterile - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: IV3000 Bulk Non Sterile

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More Product Details

Catalog Number

66604006

Brand Name

IV3000 7X9CM NON STERILE NO POUCH

Version/Model Number

66604006

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

b426bab6-6d30-4ccd-a9b1-d7871edc9022

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 07, 2021

Additional Identifiers

Package DI Number

05000223456399

Quantity per Package

10

Contains DI Package

05000223498467

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SMITH & NEPHEW MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 63
2 A medical device with a moderate to high risk that requires special controls. 126
U Unclassified 1