Aim Clear Flush - Bowel grasper, roto lok, 5mm 35 cm without ratchet - ADVANCED INSTRUMENTATION FOR MEDICINE,INC.

Duns Number:080478537

Device Description: Bowel grasper, roto lok, 5mm 35 cm without ratchet

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More Product Details

Catalog Number

-

Brand Name

Aim Clear Flush

Version/Model Number

A1-1080

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 20, 2018

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

Yes

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

c291025d-b6da-4350-b734-959c0140375b

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

June 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED INSTRUMENTATION FOR MEDICINE,INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 181