FDA.reportPublic FDA data

ETHICON

Primary DI
10705031036826
Brand
ETHICON
Company
Ethicon Inc.
Model
DW31B
Catalog number
DW31B
Device description
BONE WAX
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MTJWAX,BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTJWax, BoneUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031036823PackageGS1275In Commercial Distribution
10705031036826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503103682320705031036823
1070503103682610705031036826

GMDN Terms#

Term, Definition table
TermDefinition
Bone wax, naturalAn 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).

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
002144145
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031005235BIOPATCH415041502016-06-20
10705031005242BIOPATCH415141512016-06-20
10705031005259BIOPATCH415241522016-06-20
10705031029309ETHIBOND EXCELD8150D81502015-09-01
10705031030572ETHIBOND EXCELD8572D85722015-09-01
10705031058552ETHIBOND EXCELX997GX997G2015-09-01
10705031088351MERSILENE1765G1765G2020-04-14
10705031204553ETHIBOND EXCELD8573D85732015-09-01
10705031206403ENDOKNOTEX10GEX10G2015-09-25
10705031049703MERSILENER833HR833H2015-09-01
10705031001107BIOPATCH10150101502016-07-18
10705031001114BIOPATCH10151101512016-06-20
10705031001121BIOPATCH10152101522016-06-20
10705031206427ENDOLOOPEZ10GEZ10G2015-09-24
10705031206458ENDOKNOTJK10GJK10G2015-09-24
10705031206465ENDOLOOPEJ10GEJ10G2015-09-24
10705031206489PDSZK10GZK10G2015-09-24
10705031206885LAPRA-TYXC200XC2002015-09-25
10705031238909ETHICOND10191D101912016-09-01
10705031039551Coated VICRYLJ393HJ393H2015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255228641MERIL - BONEWAX™ MERIL ENDO SURGERY PRIVATE LIMITEDMTJ2026-03-28
08906070900214MERIL - BONEWAX™ MERIL ENDO SURGERY PRIVATE LIMITEDMTJ2026-03-28
00850391007436Montage CT 7ccABYRX, INC.MTJ2025-04-07
10884389024218MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.MTJ2024-04-24
30884389024212MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.MTJ2024-04-24
00850391007238Permatage 5ccABYRX, INC.MTJ2023-10-24
00850391007337UNM Montage Flowable Tips (3x)ABYRX, INC.MTJ2022-08-25
00850391007344UNM Montage Flowable DispenserABYRX, INC.MTJ2022-08-25
00850391007351UNM Montage Flowable SyringeABYRX, INC.MTJ2022-08-25
00850391007368UNM Montage Flowable 8ccABYRX, INC.MTJ2022-08-25
10080196024216MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.MTJ2022-08-04
30080196024210MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.MTJ2022-08-04
00850391007191Montage Flowable Syringe ABYRX, INC.MTJ2021-03-09
00850391007207Montage Flowable DispenserABYRX, INC.MTJ2021-03-09
00850391007214Montage Flowable Tips (3x)ABYRX, INC.MTJ2021-03-09
00850391007092AHBP PressABYRX, INC.MTJ2021-02-12
00850391007184Montage Fast SetABYRX, INC.MTJ2021-02-12
00850391007221Montage Flowable 8ccABYRX, INC.MTJ2021-02-12
14026704635655DEKNATELTELEFLEX INCORPORATEDMTJ2019-05-14
34026704635659DEKNATELTELEFLEX INCORPORATEDMTJ2019-05-14
00858439001538BoneSeal 2.5 gram IngotHEMOSTASIS, LLCMTJ2019-05-06
00858439001552BoneSeal 2x2.5 gram IngotHEMOSTASIS, LLCMTJ2019-05-06
00858439001514BoneSeal 3.5 gram IngotHEMOSTASIS, LLCMTJ2019-05-06
00858439001545BoneSeal 2.5 gram IngotHEMOSTASIS, LLCMTJ2019-05-06
00858439001569BoneSeal 2x2.5 gram IngotHEMOSTASIS, LLCMTJ2019-05-06
00850391007085AHBP 3.5 gramABYRX, INC.MTJ2017-08-08
00850391007177Montage 2cc MultipackABYRX, INC.MTJ2017-04-19
10850391007174Montage 2cc MultipackABYRX, INC.MTJ2017-04-19
00850391007139Hemasorb 1.0 gram with SpatulaABYRX, INC.MTJ2017-02-07
00850391007160Hemasorb 1.0 gram with SpatulaABYRX, INC.MTJ2017-02-07