trophon AcuTrace Medical Instrument Tag - RFID Medical Instrument tag - NANOSONICS LIMITED

Duns Number:741021943

Device Description: RFID Medical Instrument tag

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More Product Details

Catalog Number

-

Brand Name

trophon AcuTrace Medical Instrument Tag

Version/Model Number

N05007

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)

-

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

OUG

Product Code Name

Medical Device Data System

Device Record Status

Public Device Record Key

08bae26d-3546-4c9c-aba3-3bfbc8e5ec07

Public Version Date

July 16, 2018

Public Version Number

1

DI Record Publish Date

June 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NANOSONICS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7