N/A - HIGH FLOW TAPERED ASPIRATION TUBING 10' FOR PAL - BLACK & BLACK SURGICAL, INC.

Duns Number:004382282

Device Description: HIGH FLOW TAPERED ASPIRATION TUBING 10' FOR PAL HANDLES, STERILE, LATEX FREE 10/BOX

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More Product Details

Catalog Number

B89205

Brand Name

N/A

Version/Model Number

B89205

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

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

BYY

Product Code Name

TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Device Record Status

Public Device Record Key

94b91be6-f8fa-4d67-8066-c8859ece1a32

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BLACK & BLACK SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5533
2 A medical device with a moderate to high risk that requires special controls. 240