AccessGUDID - DEVICE: Bone Wax White (00848782008254)

GUDID

Device Identifier (DI) Information

Brand Name: Bone Wax White
Version or Model: 902
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Surgical Specialties México, S. de R.L. de C.V.

Primary DI Number: 00848782008254
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 812762226 *Terms of Use

Device Description: Bone Wax White

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?
46930	Bone wax, natural	An 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 made from natural purified beeswax (a yellowish or dark-brown wax secreted by honeybees for constructing honeycombs).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MTJ	WAX,BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K791495	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f99ac44c-b487-40f1-80b1-94056c120897
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 20, 2015