FDA.reportPublic FDA data

DEKNATEL

Primary DI
04026704590476
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN011157
Catalog number
BW-102
Device description
BONE WAX 2.5 GRAMS
Published
2015-10-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
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
24026704590470PackageGS112Not in Commercial Distribution
04026704590476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670459047024026704590470
04026704590476040267045904764026704590476

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
Length90Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00none

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Premarket exempt
true
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
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

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