A PLUS® - A PLUS PTB 2PLY HOLESLIM# 2-14 8" TOP 6" TOE X 14 - KNIT-RITE, INC

Duns Number:094737173

Device Description: A PLUS PTB 2PLY HOLESLIM# 2-14 8" TOP 6" TOE X 14

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More Product Details

Catalog Number

1TH22614

Brand Name

A PLUS®

Version/Model Number

1TH22614

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DWL

Product Code Name

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Device Record Status

Public Device Record Key

eb3f924e-a8ef-4d4f-adc9-73b68b5bfb44

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

December 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KNIT-RITE, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3930