Sapphire power supply-US (interchangeble heads) - Q-CORE MEDICAL LTD

Duns Number:533108028

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More Product Details

Catalog Number

15072-000-0008

Brand Name

Sapphire power supply-US (interchangeble heads)

Version/Model Number

15072-000-0008

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K192860,K192860,K192860

Product Code Details

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Device Record Status

Public Device Record Key

77b75fc3-7b7e-47fe-8ff8-d189d7d8b142

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 15, 2022

Additional Identifiers

Package DI Number

27290109153883

Quantity per Package

10

Contains DI Package

17290109153886

Package Discontinue Date

-

Package Status

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