ECG Electrodes - Philips Medical Systems Hsg

Duns Number:790605856

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More Product Details

Catalog Number

989803173141

Brand Name

ECG Electrodes

Version/Model Number

989803173141

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DSA

Product Code Name

CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Device Record Status

Public Device Record Key

c9f39420-2f68-42f6-9e15-585fbce0a1e0

Public Version Date

November 24, 2021

Public Version Number

7

DI Record Publish Date

March 02, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS MEDICAL SYSTEMS HSG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 323
3 A medical device with high risk that requires premarket approval 36
U Unclassified 1