Prodigy™ 2 Lok-Bar™ - 41.5cm, non-conductive - MEDTEC, INC.

Duns Number:103977526

Device Description: 41.5cm, non-conductive

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More Product Details

Catalog Number

MTIL6057

Brand Name

Prodigy™ 2 Lok-Bar™

Version/Model Number

MTIL6057

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K080072

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Device Record Status

Public Device Record Key

2f3b6f63-c94a-4f49-98d7-a9b2a11a9467

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTEC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 1027