DEKNATEL

Basic Information

• Brand Name: DEKNATEL
• Primary DI: 14026704635655
• Version / Model: IPN029172
• Catalog Number: BW-102
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-14
• Public Version: 2
• Public Version Date: 2021-07-16
• Public Version Status: Update
• Public Device Record Key: 06df0322-1f45-4240-a77f-38f7ed2468f2

Device Description

Bone Wax Contents: One (1) Bars 2.5 Grams

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MTJ	Wax, bone	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34026704635659	GS1	Box	12	In Commercial Distribution
Primary	14026704635655	GS1
Previous	04026704590476	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K050292	000