Solstice™ Thermoplastic Frame - Head-only open-face standard thermoplastic with - MEDTEC, INC.

Duns Number:103977526

Device Description: Head-only open-face standard thermoplastic with hair cover

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More Product Details

Catalog Number

MTAPCID1832SG

Brand Name

Solstice™ Thermoplastic Frame

Version/Model Number

MTAPCID1832SG

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

K182079,K182079

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Device Record Status

Public Device Record Key

2d895aa7-d2a6-4c69-b652-22d5cadefa1f

Public Version Date

July 17, 2020

Public Version Number

3

DI Record Publish Date

January 08, 2019

Additional Identifiers

Package DI Number

00841439112571

Quantity per Package

5

Contains DI Package

10841439112578

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