AccessGUDID - DEVICE: DEKNATEL (04026704590476)

GUDID

Device Identifier (DI) Information

Brand Name: DEKNATEL
Version or Model: IPN011157
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BW-102
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 04026704590476
Issuing Agency: GS1
Commercial Distribution End Date: October 04, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: BONE WAX 2.5 GRAMS

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: none

Clinically Relevant Size

[?]

Size Type Text
Length: 90 Centimeter

Device Record Status

Public Device Record Key: 651c54cd-0143-41a3-b1ad-53c45eb1cbce
Public Version Date: January 08, 2020
Public Version Number: 3
DI Record Publish Date: October 16, 2015