ADVANTA SLIDER GDS - Advanta graft, 7MMx80CM, TW, H, FLARED END, ADV, - Atrium Medical Corporation

Duns Number:051798999

Device Description: Advanta graft, 7MMx80CM, TW, H, FLARED END, ADV, AFT, GDS

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More Product Details

Catalog Number

-

Brand Name

ADVANTA SLIDER GDS

Version/Model Number

22287

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 16, 2021

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

DSY

Product Code Name

PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Record Status

Public Device Record Key

f6b9b748-b284-4fb3-a0f9-c137ff72cdaa

Public Version Date

March 22, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ATRIUM MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 161
2 A medical device with a moderate to high risk that requires special controls. 273