MD Resource - Aquavage 1200cc - MEDICAL DEVICE RESOURCE CORPORATION

Duns Number:126830020

Device Description: Aquavage 1200cc

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More Product Details

Catalog Number

AV1200D

Brand Name

MD Resource

Version/Model Number

AV1200D

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

K092284,K092284,K092284,K092284,K092284,K092284,K092284

Product Code Details

Product Code

KYZ

Product Code Name

Syringe, Irrigating (Non Dental)

Device Record Status

Public Device Record Key

343446aa-e6ea-46fe-9cd9-4b88b0acd2d5

Public Version Date

January 08, 2021

Public Version Number

7

DI Record Publish Date

September 08, 2016

Additional Identifiers

Package DI Number

60859898006241

Quantity per Package

10

Contains DI Package

00859898006249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDICAL DEVICE RESOURCE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 12