AHTO - Disposable Suction/Irrigator Tube Set - STRYKER CORPORATION

Duns Number:187502109

Device Description: Disposable Suction/Irrigator Tube Set

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More Product Details

Catalog Number

250-070-600

Brand Name

AHTO

Version/Model Number

0250070600

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

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

GCX

Product Code Name

APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Device Record Status

Public Device Record Key

f4b5c2c4-841b-451f-ae3e-e36119e7d45b

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

37613327061490

Quantity per Package

6

Contains DI Package

07613327061499

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60