FDA.reportPublic FDA data

MEDLINE INDUSTRIES

Primary DI
30080196024210
Brand
MEDLINE INDUSTRIES
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJBW25
Catalog number
DYNJBW25
Device description
WAX,BONE,NATURAL
Published
2022-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
30080196024210PackageGS112In Commercial Distribution
10080196024216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3008019602421030080196024210
1008019602421610080196024216

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).

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489086331MEDLINEMDS9082111MDS90821112026-08-27
10197344011858HUDSON RCIHUD1695HUD16952026-08-27
10197344011865HUDSON RCIHUD1694HUD16942026-08-27
10197344011872HUDSON RCIHUD1693HUD16932026-08-27
10197344011889HUDSON RCIHUD1692HUD16922026-08-27
10197344011896HUDSON RCIHUD1691HUD16912026-08-27
10197344011902HUDSON RCIHUD1690HUD16902026-08-27
10197344011919HUDSON RCIHUD1689HUD16892026-08-27
10197344011926HUDSON RCIHUD1688HUD16882026-08-27
10197344011933HUDSON RCIHUD1687HUD16872026-08-27
10197344011940HUDSON RCIHUD1686HUD16862026-08-27
10197344011957HUDSON RCIHUD1685HUD16852026-08-27
10197344011964HUDSON RCIHUD1683HUD16832026-08-27
10197344016884HUDSON RCIHUD2701LHUD2701L2026-08-27
10197344016891HUDSON RCIHUD2701MHUD2701M2026-08-27
10197344016938HUDSON RCIHUD2701SHUD2701S2026-08-27
10197344016945HUDSON RCIHUD2701XLHUD2701XL2026-08-27
10197344016969HUDSON RCIHUD2702HUD27022026-08-27
10197344016976HUDSON RCIHUD2703HUD27032026-08-27
10197344016983HUDSON RCIHUD2704HUD27042026-08-27

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
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