FDA.report

ETHICON

Primary DI
30705031056996
Brand
ETHICON
Company
ETHICON, LLC
Model
W31G
Catalog number
W31G
Device description
BONE WAX
Published
2015-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MTJWAX,BONE

Product Code Classifications

CodeDeviceSpecialtyClass
MTJWax, BoneUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30705031056996PackageGS112In Commercial Distribution
10705031056992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3070503105699630705031056996
1070503105699210705031056992

GMDN Terms

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).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags

DUNS number
829465157
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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30705031049097PRONOVAPN489GPN489G2026-01-07
30705031049103PRONOVAPN496GPN496G2026-01-07
30705031049172PRONOVAPN584GPN584G2026-01-07
30705031246175PRONOVAPN3558HPN3558H2026-01-07
30705031097234PROLENEEH7583HEH7583H2025-11-11
30705031098439PROLENEEH7835HEH7835H2025-11-11
30705031116201PROLENEF1880F18802025-11-11
30705031098477PROLENEEH7897GEH7897G2025-04-22
30705031228348PROLENEEP8729HEP8729H2025-04-22
30705031228621PROLENEEP8767HEP8767H2025-04-22
30705031237807PROLENEW753GW753G2025-04-22
30705031050864ETHICONTPW10TPW102015-09-24
10705031050877ETHICONTPW20TPW202015-09-01
10705031050884ETHICONTPW30TPW302015-09-01
10705031050891ETHICONTPW32TPW322015-09-01

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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
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
34026704635659DEKNATELTELEFLEX INCORPORATEDMTJ2019-05-14
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
10850391007174Montage 2cc MultipackABYRX, INC.MTJ2017-04-19
00850391007160Hemasorb 1.0 gram with SpatulaABYRX, INC.MTJ2017-02-07
10850391007068Hemasorb Press 4.0 gramABYRX, INC.MTJ2017-01-25
00850391007153Hemasorb 2.0 gram with SpatulaABYRX, INC.MTJ2017-01-24
00850391007146Abyrx SpatulaABYRX, INC.MTJ2017-01-24
00850391007009Hemasorb PlusABYRX, INC.MTJ2016-12-15
10850391007075AHBP 2.5 gram ABYRX, INC.MTJ2016-12-14
00850391007108Hemasorb Plus ABYRX, INC.MTJ2016-12-13
00850391007122Montage 5ccABYRX, INC.MTJ2016-11-21
00850391007030Hemasorb 2.0 gram ABYRX, INC.MTJ2016-11-16
00850391007054Hemasorb ApplyABYRX, INC.MTJ2016-11-03