N/A - KIT, TOSHIBA INFINIX HEADHOLDER ACCESSORY. - DOMICO MED-DEVICE, LLC

Duns Number:081253414

Device Description: KIT, TOSHIBA INFINIX HEADHOLDER ACCESSORY. Includes: 9402 - INFINIX MANDIBULAR SUPPORT PAD KIT, TOSHIBA INFINIX HEADHOLDER ACCESSORY. Includes: 9402 - INFINIX MANDIBULAR SUPPORT PADS (10810050242735), 9403 - INFINIX FOREHEAD PAD & STRAP (00810050243223), 9404 - INFINIX CHIN STRAP (00810050241311), 9405 - INFINIX NECK SUPPORT PADS (00810050243230), 9408 - INFINIX HEAD SUPPORT PAD (00810050241328)

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

9411

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

cb9d40c8-25bc-4853-bb13-580dc08ba867

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DOMICO MED-DEVICE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 512
2 A medical device with a moderate to high risk that requires special controls. 35