NA - Radiotranslucent DIN SKT 48 Inch Leadwire - Conmed Corporation

Duns Number:071595540

Device Description: Radiotranslucent DIN SKT 48 Inch Leadwire

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More Product Details

Catalog Number

RTRG48-05

Brand Name

NA

Version/Model Number

RTRG48-05

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 05, 2020

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

K912415

Product Code Details

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Device Record Status

Public Device Record Key

57c2af89-1480-433a-bde0-3e9208196e64

Public Version Date

December 07, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95