PRO1TEK IFAK EMT CCR Leg RIG BAG - PRO1TEK IFAK EMT CCR Leg Rig Bag with Hemostatic - Pro1tek

Duns Number:827067880

Device Description: PRO1TEK IFAK EMT CCR Leg Rig Bag with Hemostatic Dressing, CAT-T, Hyfin Chest Seal, Trauma PRO1TEK IFAK EMT CCR Leg Rig Bag with Hemostatic Dressing, CAT-T, Hyfin Chest Seal, Trauma Shears, NPA 28, Olaes Bandage and other Medical Supplies.

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More Product Details

Catalog Number

-

Brand Name

PRO1TEK IFAK EMT CCR Leg RIG BAG

Version/Model Number

B283P1FDPD20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

-

Product Code Details

Product Code

OVR

Product Code Name

Kit, First Aid, Talking

Device Record Status

Public Device Record Key

5db0607a-eb8f-4558-9313-d7741ff98d2f

Public Version Date

June 04, 2021

Public Version Number

1

DI Record Publish Date

May 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRO1TEK" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29