Spectrum, Inc. - Hy'N Dry Stockinette, Impervious, 10" X 4', with - SPECTRUM, INC.

Duns Number:080458964

Device Description: Hy'N Dry Stockinette, Impervious, 10" X 4', with straps, Sterile

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More Product Details

Catalog Number

705134

Brand Name

Spectrum, Inc.

Version/Model Number

985-03537-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

FQL

Product Code Name

STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)

Device Record Status

Public Device Record Key

74d63d93-48b5-4177-a5bd-b1609da9bace

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 14, 2017

Additional Identifiers

Package DI Number

10855495007112

Quantity per Package

12

Contains DI Package

00855495007115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"SPECTRUM, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 66
2 A medical device with a moderate to high risk that requires special controls. 16
U Unclassified 11