ADVANCED TABLE, OPERATING-ROOM, ELECTRICAL - ADVANCED INSTRUMENTATIONS, INC.

Duns Number:608736880

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More Product Details

Catalog Number

-

Brand Name

ADVANCED TABLE, OPERATING-ROOM, ELECTRICAL

Version/Model Number

OT-400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 30, 2028

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

GDC

Product Code Name

Table, Operating-Room, Electrical

Device Record Status

Public Device Record Key

55284b95-5e46-4094-bc8c-1871492451f4

Public Version Date

June 04, 2020

Public Version Number

1

DI Record Publish Date

May 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED INSTRUMENTATIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 32