SpandaNette - SpandaNette Tubular Cotton Stockinette Single Ply - MEDI-TECH INTERNATIONAL CORPORATION

Duns Number:063865158

Device Description: SpandaNette Tubular Cotton Stockinette Single Ply - Natural - Size 6 - Non-Sterile

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More Product Details

Catalog Number

MTSN13625

Brand Name

SpandaNette

Version/Model Number

MTSN13625

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMP

Product Code Name

Protector, Skin Pressure

Device Record Status

Public Device Record Key

b8cad8c5-9b55-4c9c-b3e9-76380c9adfff

Public Version Date

November 06, 2019

Public Version Number

1

DI Record Publish Date

October 29, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDI-TECH INTERNATIONAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 226
2 A medical device with a moderate to high risk that requires special controls. 1