ComPel Single Wrap - COMPEL SINGLE WRAP KAUM 45X45 - RM (98 7733) USE: - STANDARD TEXTILE CO., INC.

Duns Number:006999858

Device Description: COMPEL SINGLE WRAP KAUM 45X45 - RM (98 7733) USE: 27666502

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More Product Details

Catalog Number

27627802

Brand Name

ComPel Single Wrap

Version/Model Number

27627802

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

-

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

K923408,K923408

Product Code Details

Product Code

FRG

Product Code Name

Wrap, Sterilization

Device Record Status

Public Device Record Key

84e51ab8-2558-4441-878b-daaba0bd6aa7

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

January 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANDARD TEXTILE CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 9