NA - ACCESSORY KIT, CARTESION PRIME. Includes: 9006 - - DOMICO MED-DEVICE, LLC

Duns Number:081253414

Device Description: ACCESSORY KIT, CARTESION PRIME. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRA ACCESSORY KIT, CARTESION PRIME. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP, FOREHEAD W/ADULT PAD (00810050242134), 9008 - KIT, ADULT HEAD REST (00810050243209), 9009 - WEDGE, TILT (00810050242431), 9017 - WEDGE, KNEE, 10.7” x 21.88” x 18.33” (00810050242424), 9020F - PAD, PEDIATRIC POSITIONING (00810050241441), 9025 - HOLDER, CORONAL HEAD (00810050241229), 9061 – STRAP, WIDE SECURITY, 14.17” x 21.12” (20810050242909), 9062 - STRAP, NARROW SECURITY FOR THE SHIELD (20810050242886), 9080 - SLIDE RAIL, DETACHABLE, AQULION ONE (10810050242841), 9092 - PAD, AQUILION ONE ADULT HOLDER (00810050241380), 9093 - PAD, AQUILION ONE CHILD HOLDER (00810050241397), 9094 - PAD, AQUILION ONE PEDIATRIC HOLDER (00810050242448), 9095 - PAD, AQUILION ONE WEDGE (00810050241403), 9096 - WEDGE, TAPER, 1.5” x 3.5” x 3” (10810050243008), 9097 - STRAP, VELTEX, 2” x 22” (10810050242896), 9112 - COVER, PROTECTIVE, FOOT EXTENSION PAD (10810050242674), 9113 - STRAP, WIDE BARIATRIC EXTENDER 30" (00810050242172), 9114 - STRAP, NARROW BARIATRIC EXTENDER 30" (00810050242158), 9121 – TABLE PAD COVER (00861001002659), 9122 – TABLE PAD, CARTESION PRIME (00810050244572), 9123 – FOOT PAD, CARTESION PRIME (00810050244589)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

9124

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

8c7c9c9c-d504-4824-8632-d82a475ddf21

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 20, 2021

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