AccessGUDID - DEVICE: DEKNATEL (14026704635655)

GUDID

Device Identifier (DI) Information

Brand Name: DEKNATEL
Version or Model: IPN029172
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BW-102
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704635655
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704590476

Device Description: Bone Wax Contents: One (1) Bars 2.5 Grams

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 [?]
K050292	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: 06df0322-1f45-4240-a77f-38f7ed2468f2
Public Version Date: July 16, 2021
Public Version Number: 2
DI Record Publish Date: May 14, 2019