BoneSeal 3.5 gram Ingot

GUDID 00858439001514

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.

HEMOSTASIS, LLC

Bone wax, synthetic
Primary Device ID00858439001514
NIH Device Record Key16786ac5-3760-4248-89ad-b661f06ce721
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoneSeal 3.5 gram Ingot
Version Model Number9550034
Company DUNS801380697
Company NameHEMOSTASIS, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 651-855-1466
Emailcustomerservice@hemostasisllc.com

Device Dimensions

Weight3.5 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not expose product to temperature in excess of 60 degrees Celsius. Once product package is opened, contents may be subject to contamination. Discard any unused product.

Device Identifiers

Device Issuing AgencyDevice ID
GS100858439001514 [Primary]
GS100858439001521 [Package]
Package: Carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MTJWax, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-14
Device Publish Date2019-05-06

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00858439001774 - AeroClear2020-12-08 The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. I
00858439001705 - ExcelArrest XT 2x2 Hemostatic Patch2020-11-30 ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in ste
00858439001293 - NexStat Plus 2gm2020-10-08 The Hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide
00858439001408 - NexStat Plus 3gm2020-10-08 The hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide
00858439001439 - NexStat2020-10-08 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th

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