AccessGUDID - DEVICE: BoneSeal 3.5 gram Ingot (00858439001514)

GUDID

Device Identifier (DI) Information

Brand Name: BoneSeal 3.5 gram Ingot
Version or Model: 9550034
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEMOSTASIS, LLC

Primary DI Number: 00858439001514
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801380697 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44811	Bone wax, synthetic	A sterile, implantable device in the form of a sterile wax-like, putty-like, or paste material designed to stop bone bleeding by the creation of a physical barrier along the edges of bone that has been damaged by trauma or cut during a surgical procedure. When placed on the bone under moderate pressure it plugs the vascular openings in the bone and prevents further bleeding. It is typically made from biocompatible/bioabsorbable synthetic substances (e.g., water-soluble copolymers); its stickiness may be increased by warming and by additional handling and manipulation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MTJ	Wax, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142348	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: 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.

Clinically Relevant Size

[?]

Size Type Text
Weight: 3.5 Gram

Device Record Status

Public Device Record Key: 16786ac5-3760-4248-89ad-b661f06ce721
Public Version Date: May 14, 2019
Public Version Number: 1
DI Record Publish Date: May 06, 2019