BoneSeal 2.5 gram Ingot - The Hemostasis BoneSeal Bone Hemostat stops bone - HEMOSTASIS, LLC

Duns Number:801380697

Device Description: The Hemostasis BoneSeal Bone Hemostat stops bone bleeding by establishing a physical barri The Hemostasis BoneSeal Bone Hemostat stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, BoneSeal forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure.BoneSeal is based upon known biodegradable polymeric chemistry that forms a ready-to-use hemostatic agent. BoneSeal is available as a bone hemostat ingot of various masses. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone and applied to the bleeding area.

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More Product Details

Catalog Number

-

Brand Name

BoneSeal 2.5 gram Ingot

Version/Model Number

9550054

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

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

K142348,K142348

Product Code Details

Product Code

MTJ

Product Code Name

Wax, Bone

Device Record Status

Public Device Record Key

d0c42de9-265a-48f7-9fcf-fa5079b333fd

Public Version Date

May 14, 2019

Public Version Number

1

DI Record Publish Date

May 06, 2019

Additional Identifiers

Package DI Number

00858439001545

Quantity per Package

5

Contains DI Package

00858439001538

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"HEMOSTASIS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
U Unclassified 7