AED-SLT KIT - A complete set of AED-SLT hermetic seal testers - NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Duns Number:839138955

Device Description: A complete set of AED-SLT hermetic seal testers for Midas Rex, Stryker, Dyonics, Conmed Li A complete set of AED-SLT hermetic seal testers for Midas Rex, Stryker, Dyonics, Conmed Linvatec and Arthrex medical power tools including a hand-held aneroid sphygmomanometer with pressure inflation bulb

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More Product Details

Catalog Number

AED-SLT KIT

Brand Name

AED-SLT KIT

Version/Model Number

AED-SLT KIT

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEY

Product Code Name

Motor, Surgical Instrument, Ac-Powered

Device Record Status

Public Device Record Key

8d2d8c84-59fb-4bfc-8c59-57c435a1b337

Public Version Date

August 06, 2020

Public Version Number

1

DI Record Publish Date

July 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATIONAL ADVANCED ENDOSCOPY DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 579
2 A medical device with a moderate to high risk that requires special controls. 6418