FDA.reportPublic FDA data

Ostene

Primary DI
55413760467455
Brand
Ostene
Company
Apatech Ltd
Model
1503831
Catalog number
1503831
Device description
Bone Hemostasis Material - 3.5g
Published
2015-09-24
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

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
55413760467455PackageGS110In Commercial Distribution
05413760467450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5541376046745555413760467455
05413760467450054137604674505413760467450

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight3.5Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00OSTENE should not be subjected to excess heat. Store away from direct heat, including sunlight.
Storage Environment Temperature0 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
221517829
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05413760467450Ostene150383115038312015-09-24
05413760467467Ostene150383215038322015-09-24
05413760467474Ostene150383315038332015-09-24
05060050780289Actifuse Granules5060050780285060050780282015-09-24
05060050780296Actifuse Granules5060050780295060050780292015-09-24
05060050780302Actifuse Granules5060050780305060050780302015-09-24
05060050780449Actifuse Microgranules5060050780445060050780442015-09-24
05060050780456Actifuse Microgranules5060050780455060050780452015-09-24
05060050780463Actifuse Microgranules5060050780465060050780462015-09-24
05060050780500Actifuse ABX5060050780505060050780502015-09-24
05060050780517Actifuse ABX5060050780515060050780512015-09-24
05060050780524Actifuse ABX5060050780525060050780522015-09-24
05060050780548Actifuse E-Z-Prep5060050780545060050780542015-09-24
05060050780562Actifuse Granules5060050780565060050780562015-09-24
05060050780586Actifuse ABX5060050780585060050780582015-09-24
05060050780609Actifuse ABX5060050780605060050780602015-09-24
05060050780623Actifuse Shape5060050780625060050780622015-09-24
05060050780647Actifuse Shape5060050780645060050780642015-09-24
05060050780661Actifuse Shape5060050780665060050780662015-09-24
05060050780685Actifuse Shape5060050780685060050780682015-09-24

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