FDA.reportPublic FDA data

MEDLINE INDUSTRIES

Primary DI
10884389024218
Brand
MEDLINE INDUSTRIES
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJBW26
Catalog number
DYNJBW26
Device description
WAX,BONE,SYNTHETIC
Published
2024-04-24
Public version status
New
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
30884389024212PackageGS112In Commercial Distribution
10884389024218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088438902421230884389024212
1088438902421810884389024218

GMDN Terms#

Term, Definition table
TermDefinition
Bone wax, syntheticA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature21 Degrees Celsius23 Degrees Celsius
Special Storage Condition, Specify00Protect from freezing. Avoid excessive heat. Shield from direct sunlight. Keep Dry.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

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
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
00850391007061Hemasorb Press 4.0 gramABYRX, INC.MTJ2017-01-25