3M™ Durapore™ - 3M™ Durapore™ Surgical Tape, 1538-118, 1 in x 18 - 3M Deutschland GmbH

Duns Number:315731711

Device Description: 3M™ Durapore™ Surgical Tape, 1538-118, 1 in x 18 in, Bulk, 800 Rolls/Case

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More Product Details

Catalog Number

1538-118

Brand Name

3M™ Durapore™

Version/Model Number

1538-118

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

-

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

KGX

Product Code Name

Tape and bandage, adhesive

Device Record Status

Public Device Record Key

ddf9fd60-b709-462a-a56f-b2a34c93cdcd

Public Version Date

January 18, 2021

Public Version Number

1

DI Record Publish Date

January 08, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3M DEUTSCHLAND GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 232
2 A medical device with a moderate to high risk that requires special controls. 563
U Unclassified 3