Type-S™ Thermoplastic - 25.4cm head-only IMRT Style 20 thermoplastic - MEDTEC, INC.

Duns Number:103977526

Device Description: 25.4cm head-only IMRT Style 20 thermoplastic (2.4mm)

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More Product Details

Catalog Number

MTAPUID2024

Brand Name

Type-S™ Thermoplastic

Version/Model Number

MTAPUID2024

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,K093738,K933227,K080072,K093738,K933227

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Device Record Status

Public Device Record Key

bd3e1e30-8681-4331-ac9e-6ef9880e8f2e

Public Version Date

August 03, 2020

Public Version Number

7

DI Record Publish Date

September 25, 2017

Additional Identifiers

Package DI Number

00841439103692

Quantity per Package

5

Contains DI Package

10841439103699

Package Discontinue Date

-

Package Status

In Commercial Distribution

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