Sapphire Power Supply (fixed head) - Sapphire Power Supply (fixed head) with plastic - Q-CORE MEDICAL LTD

Duns Number:533108028

Device Description: Sapphire Power Supply (fixed head) with plastic ODU connector

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More Product Details

Catalog Number

15072-000-0007-ASM

Brand Name

Sapphire Power Supply (fixed head)

Version/Model Number

15072-000-0007-ASM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2017

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K123049,K123049,K123049

Product Code Details

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Device Record Status

Public Device Record Key

feaa9a06-1c9e-499a-8476-599cb5310b77

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

27290109150059

Quantity per Package

50

Contains DI Package

17290109150052

Package Discontinue Date

June 29, 2017

Package Status

Not in Commercial Distribution

Package Type

cardboard box

"Q-CORE MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 65