CHOLE KIT 16 - Kit Contains:C0R47, 12x100 Kii BALLOON BLUNT TIP - APPLIED MEDICAL RESOURCES CORPORATION

Duns Number:187129135

Device Description: Kit Contains:C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BXCB030, 5mmx35cm EPIX LAPA SCISSOR, 10 Kit Contains:C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BXCB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BXC6001, 5mmX33cm PROB/VALV DUAL BAG 12/BXCD001, 10mm RETRIEVAL SYSTEM, 10/BXCFB73, 12x100 Kii SH BLD ADVFIX 6/BXCFS02, 5x100 Kii SLEEVE ADVFIX 12/BXCFB03, 5x100 Kii SH BLD ADVFIX, 6/BXCA090, DIRECT DRIVE LCA 3/BX

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More Product Details

Catalog Number

-

Brand Name

CHOLE KIT 16

Version/Model Number

GK316

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

Yes

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

FHF

Product Code Name

System, Evacuator, Fluid

Device Record Status

Public Device Record Key

b4e6f2f9-1680-457a-bf48-1902a40ebfd9

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 09, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"APPLIED MEDICAL RESOURCES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 499
2 A medical device with a moderate to high risk that requires special controls. 698
3 A medical device with high risk that requires premarket approval 1