SURGIPLUS - Scrub Pant, LA non-sterile, two-piece garment - KENPAX INTERNATIONAL LIMITED

Duns Number:686206765

Device Description: Scrub Pant, LA non-sterile, two-piece garment designed to be worn by healthcare staff to f Scrub Pant, LA non-sterile, two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

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More Product Details

Catalog Number

68-7174-B

Brand Name

SURGIPLUS

Version/Model Number

1

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)

-

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

LYU

Product Code Name

Accessory, Surgical Apparel

Device Record Status

Public Device Record Key

6c400dba-63c4-40ac-aba9-488156a3b7d0

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 22, 2020

Additional Identifiers

Package DI Number

84895237108047

Quantity per Package

70

Contains DI Package

74895237108040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"KENPAX INTERNATIONAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 9