FDA.reportPublic FDA data

MED V+

Primary DI
03760177042186
Brand
MED V+
Company
TEKNIMED
Model
T060417
Catalog number
T060417
Published
2020-09-28
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

Product Codes#

Code, Name table
CodeName
OARInjector, Vertebroplasty (Does Not Contain Cement)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760177042186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177042186037601770421863760177042186

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
764746723
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
03701505801204DynamoSpinal Cement – MV11-59202026-02-02
03701505801211Dynamo Spinal Cement System Syringe MV 1.5cc11-59212026-02-02
03701505801228DynamoSpinal Cement System Syringe MV 4cc11-59222026-02-02
03701505801235DynamoSpinal Cement System Gun MV11-59232026-02-02
03760177044326Signature -x Cement SVP/N191-14-40002026-01-23
03760177044333Signature -x Cement LVP/N191-14-40012026-01-23
03760177044340Signature -x Cement MVMVP/N191-14-40022026-01-23
03760177040090GENTAFIX1T040140G2025-09-02
03760177040137GENTAFIX3T040340G2025-09-02
03760177043176GENTAFIX3 MVT040341G2025-09-02
03701505801020PureKit Syringe 1.5cc MVT060428MV2025-03-31
03701505801037META+ System 1.5cc MVT040352MV2025-03-31
03701505801075PUREKIT SyringesT0604262025-03-31
03701505801082Syringes 4ccT0604272025-03-31
03701505801099Syringes 1.5ccT0604282025-03-31
03760177045361PureKit Gun MVT060425MV2023-03-30
03760177040113OPACITY +T040320ZT040320Z2015-10-16
03760177041110F20T040520T0405202015-10-16
03760177041721HIGH V+T040321T0403212017-08-22
03760177042391EXOFIXT040323T0403232015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053175003439Vertebroplasty Injector KitADRIA SRLOAR2025-04-07
08053175004382Cement Injection CannulaADRIA SRLOAR2025-04-07
03701505801075PUREKIT SyringesTEKNIMEDOAR2025-03-31
03701505801082Syringes 4ccTEKNIMEDOAR2025-03-31
03701505801099Syringes 1.5ccTEKNIMEDOAR2025-03-31
10884450837549StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-12-20
10884450833961DiamondTOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-11-16
00815212026935Duro-Ject Bone Cement Injection TubeIzi Medical Products, LLCOAR2024-10-14
08058964724960VHP GUNG21 SRLOAR2024-10-14
08033860022693BIOPSYBELLBIOPSYBELL SRLOAR2024-02-23
08800038054332MEDINAUT-VIMEDICOM CO., LTD.OAR2023-08-31
08800038054349MEDINAUT-VIMEDICOM CO., LTD.OAR2023-08-31
08800038055674SYNTH™ VRTIMEDICOM CO., LTD.OAR2023-08-30
08800038055681SYNTH™ VRTIMEDICOM CO., LTD.OAR2023-08-30
00884450492284StabiliT®Merit Medical Systems, Inc.OAR2023-07-08
08033860015435BIOPSYBELLBIOPSYBELL SRLOAR2023-06-16
08033860017521BIOPSYBELLBIOPSYBELL SRLOAR2023-06-16
08033860022419BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860023102BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860026592BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860034740BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860039417BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
10884450662141StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2022-10-04
08033860030223BIOPSYBELLBIOPSYBELL SRLOAR2022-09-29
08033860036591BIOPSYBELLBIOPSYBELL SRLOAR2022-09-29
08033860024567BIOPSYBELLBIOPSYBELL SRLOAR2022-09-28
28031497001702MENDEC AQUATECRES SPAOAR2022-09-23
28031497002006MENDEC AQUA CARTRIDGE TECRES SPAOAR2022-09-23
08033860016739BIOPSYBELLBIOPSYBELL SRLOAR2022-09-19
08033860016760BIOPSYBELLBIOPSYBELL SRLOAR2022-09-19