FDA.reportPublic FDA data

NA

Primary DI
10705034721743
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
03.702.221S
Catalog number
03702221S
Device description
VERTEBROPLASTY NEEDLE KIT 12G BEVELED TIP
Published
2016-12-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIHDISPENSER, CEMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIHDispenser, CementOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819371293Direct MarkingGS10
10705034721743PrimaryGS10
H98103702221S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819371293076118193712937611819371293
1070503472174310705034721743

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034731650NA03.820.126038201262016-12-31
10705034731667NA03.820.127038201272016-12-31
10705034731674NA03.820.128038201282016-12-31
10705034731681NA03.820.129038201292016-12-31
10705034731759NA03.820.136038201362016-12-31
10705034731766NA03.820.137038201372016-12-31
10705034731896PRODISC L03.820.201038202012016-12-31
10705034731902PRODISC L03.820.202038202022016-12-31
10705034732008NA03.820.459038204592016-12-31
10705034732015NA03.820.462038204622016-12-31
10705034763729ProDisc-C09.820.025S09820025S2014-09-08
10705034763736ProDisc-C09.820.026S09820026S2014-09-08
10705034763750ProDisc-C09.820.035S09820035S2014-09-08
10705034763767ProDisc-C09.820.036S09820036S2014-09-08
10705034763781ProDisc-C09.820.045S09820045S2014-09-08
10705034763798ProDisc-C09.820.046S09820046S2014-09-08
10705034763804ProDisc-C09.820.047S09820047S2014-09-08
10705034763811ProDisc-C09.820.055S09820055S2014-09-08
10705034763828ProDisc-C09.820.056S09820056S2014-09-08
10705034763835ProDisc-C09.820.057S09820057S2014-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAKIH2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAKIH2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAKIH2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAKIH2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAKIH2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAKIH2025-12-17
06923558507569Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.KIH2025-10-23
06923558509693Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.KIH2025-10-23
08053617184450PressurizerADLER ORTHO SPAKIH2025-10-07
08053617184467PressurizerADLER ORTHO SPAKIH2025-10-07
08053617184474PressurizerADLER ORTHO SPAKIH2025-10-07
08053617184481PressurizerADLER ORTHO SPAKIH2025-10-07
08053617183750PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183767PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183774PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183781PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183798PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183804PressurizerADLER ORTHO SPAKIH2025-08-07
08053617184498PressurizerADLER ORTHO SPAKIH2025-08-07
06951233720842PALAGUN®Guangzhou Clean Medical Products Manufacturing Corp.KIH2025-06-05
00763000883461N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000883478N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000883485N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000242510MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.KIH2025-05-11
15060238201633HiVac™ 7 Triple Mix SUMMIT MEDICAL LIMITEDKIH2025-01-10
15060238201657HiVac™ 7 with Femoral Cement Pressuriser SUMMIT MEDICAL LIMITEDKIH2025-01-10
15060238201671HiVac™ SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
15060238201688HiVac™ SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
150602382017189mm Nozzle With Nozzle ExtruderSUMMIT MEDICAL LIMITEDKIH2025-01-10
15060238201770Cement Mixing and Delivery SystemSUMMIT MEDICAL LIMITEDKIH2025-01-10