NA - Small Hand Sealer Clips - BAXTER INTERNATIONAL INC.

Duns Number:005146311

Device Description: Small Hand Sealer Clips

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More Product Details

Catalog Number

2B8045

Brand Name

NA

Version/Model Number

2B8045

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 30, 2022

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)

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

NEP

Product Code Name

SYSTEM/DEVICE, PHARMACY COMPOUNDING

Device Record Status

Public Device Record Key

1e81bff3-79bf-4200-b593-a0e9f3d6216e

Public Version Date

June 27, 2022

Public Version Number

6

DI Record Publish Date

January 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BAXTER INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 358