masterguard plus HEMODIALYSIS FISTULA NEEDLE SET - SINGLE PACK FISTULA NEEDLE 15G X 1" WITH - NXSTAGE MEDICAL, INC.

Duns Number:088013219

Device Description: SINGLE PACK FISTULA NEEDLE 15G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2005MG SINGLE PACK FISTULA NEEDLE 15G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2005MGP

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More Product Details

Catalog Number

-

Brand Name

masterguard plus HEMODIALYSIS FISTULA NEEDLE SET

Version/Model Number

D9-7005MGP

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"

Yes

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

FIE

Product Code Name

Needle, Fistula

Device Record Status

Public Device Record Key

2d9140f3-c202-4c3f-b66b-2ef05eaf5579

Public Version Date

June 17, 2020

Public Version Number

1

DI Record Publish Date

June 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NXSTAGE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 211