Bone Wax

GUDID 20884521196268

Bone Wax

Covidien LP

Bone wax, natural
Primary Device ID20884521196268
NIH Device Record Keycffece2d-7c17-4e33-912c-fb52feee5155
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Wax
Version Model NumberBW25G
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521196261 [Primary]
GS120884521196268 [Package]
Contains: 10884521196261
Package: CASE [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MTJWAX,BONE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-05-16
Device Publish Date2015-08-31

Devices Manufactured by Covidien LP

20884521837468 - DAR2025-02-18 Adult-Pediatric Electrostatic Filter HME Small, Tethered Cap
20884521837482 - DAR2025-02-18 Adult-Pediatric Electrostatic Filter HME with Connector Small, Tethered Cap
20884521827636 - EEA2025-02-17 CIR STPLR TRIEEAXL21MT wTRISTP nORVL
20884521827643 - EEA2025-02-17 CIR STPLR TRIEEAXL21XT BLK wTRISTP nORVL
20884521827650 - EEA2025-02-17 CIR STPLR TRIEEAXL25MT wTRISTP nORVL
20884521827667 - EEA2025-02-17 CIR STPLR TRIEEAXL25XT BLK wTRISTP nORVL
20884521828992 - DAR2025-02-17 Adult Electrostatic Filter HME Large
20884521829029 - DAR2025-02-17 Adult Electrostatic Filter HME with Catheter Mount Large

Trademark Results [Bone Wax]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BONE WAX
BONE WAX
87258714 not registered Dead/Abandoned
Surgical Specialties Corporation (US), Inc.
2016-12-06

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.