AIM LAP - SUCTION COAG W/ SPAT TIP INS 5MM 330MM - ADVANCED INSTRUMENTATION FOR MEDICINE,INC.

Duns Number:080478537

Device Description: SUCTION COAG W/ SPAT TIP INS 5MM 330MM

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More Product Details

Catalog Number

-

Brand Name

AIM LAP

Version/Model Number

A5-300

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

-

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

92764fa5-b207-4df9-a11e-93cdae87dff0

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

March 13, 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