Catalog Number

758607015

Brand Name

SKATER™ Mini-Loop Drainage Set

Version/Model Number

758607015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

GBO

Product Code Name

Catheter, Nephrostomy, General & Plastic Surgery

Public Device Record Key

68ced945-fec8-45e9-8681-6be1d4017969

Public Version Date

July 22, 2022

Public Version Number

1

DI Record Publish Date

July 14, 2022

Package DI Number

20886333225372

Quantity per Package

5

Contains DI Package

00886333225378

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box