FDA.reportPublic FDA data

BIOPSYBELL

Primary DI
08033860028787
Brand
BIOPSYBELL
Company
BIOPSYBELL SRL
Model
RENOVA SPINE KYPHOPLASTY TOOL KIT
Catalog number
RESFAST11-001
Device description
KYPHOPLASTY TOOL KIT
Published
2020-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCJSpinal Channeling Instrument, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCJSpinal Channeling Instrument, VertebroplastyOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033860028787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033860028787080338600287878033860028787

GMDN Terms#

Term, Definition table
TermDefinition
Balloon kyphoplasty kitA collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge10Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+39053527850medical@biopsybell.it

Regulatory Flags#

DUNS number
438746708
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
08033860002008BIOPSYBELLUNLUX SYSTEMULSEC1115C2021-03-12
08033860046613BIOPSYBELLRENOVA SPINE KYPHOPLASTY TOOL KITRESFAST11-0032025-10-27
08033860021597SOMATEXSOMACORE VERIFY900380-US2016-08-01
08033860021610SOMATEXSOMACORE VERIFY900382-US2016-08-01
08033860021634SOMATEXSOMACORE VERIFY900390-US2016-08-01
08033860021658SOMATEXSOMACORE VERIFY900392-US2016-08-01
08033860021672SOMATEXSOMACORE VERIFY900400-US2016-08-01
08033860021696SOMATEXSOMACORE VERIFY900402-US2016-08-01
08033860021719SOMATEXSOMACORE VERIFY900404-US2016-08-01
08033860021733SOMATEXSOMACORE VERIFY900410-US2016-08-01
08033860021757SOMATEXSOMACORE VERIFY900412-US2016-08-01
08033860021771SOMATEXSOMACORE VERIFY S900480-US2016-08-01
08033860021795SOMATEXSOMACORE VERIFY S900490-US2016-08-01
08033860021818SOMATEXSOMACORE VERIFY S900492-US2016-08-01
08033860021832SOMATEXSOMACORE VERIFY S900500-US2016-08-01
08033860021856SOMATEXSOMACORE VERIFY S900502-US2016-08-01
08033860021603SOMATEXSOMACORE VERIFY900380-US2016-08-01
08033860021627SOMATEXSOMACORE VERIFY900382-US2016-08-01
08033860021641SOMATEXSOMACORE VERIFY900390-US2016-08-01
08033860021665SOMATEXSOMACORE VERIFY900392-US2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAOCJ2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAOCJ2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAOCJ2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAOCJ2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAOCJ2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAOCJ2025-12-17
08033860046613BIOPSYBELLBIOPSYBELL SRLOCJ2025-10-27
06923558507569Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.OCJ2025-10-23
06923558509693Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.OCJ2025-10-23
08809281659806TVP System (Vertebra Plasty SET B)Taeyeon Medical co.,Ltd.OCJ2025-09-03
08809281659417PCD SystemTaeyeon Medical co.,Ltd.OCJ2025-08-22
00815212026973BLAZER-C CURVED INJECTION SYSTEM-MVIzi Medical Products, LLCOCJ2025-05-21
B90829211908Main-AXS Needle-RetropsoasMainstream Medical Devices, LLCOCJ2025-04-30
08053175016125Vertebroplasty NeedleADRIA SRLOCJ2025-04-07
B908350008000Main-AXS Needle-Spinal SimplicityMainstream Medical Devices, LLCOCJ2024-12-03
B908350009000Main-AXS Needle-Spinal SimplicityMainstream Medical Devices, LLCOCJ2024-12-03
08800046100380CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-10-29
08800046101080CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-10-29
08800046101202CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-10-29
08058964724687V-AccessG21 SRLOCJ2024-10-16
08058964725356V-AccessG21 SRLOCJ2024-10-16
08058964725363V-AccessG21 SRLOCJ2024-10-16
08058964725417V-AccessG21 SRLOCJ2024-10-16
08058964724021KeyFix Direct Access NeedleG21 SRLOCJ2024-10-10
08058964724052KeyFix Bone Cement Filler CannulaG21 SRLOCJ2024-10-10
08058964724083KeyFix Bone Cement Filler CannulaG21 SRLOCJ2024-10-10
08058964724113KeyFix Direct Access NeedleG21 SRLOCJ2024-10-10
08058964725431V-AccessG21 SRLOCJ2024-10-10
08058964725448V-AccessG21 SRLOCJ2024-10-10
08058964727725Keyfix direct access needle 8GG21 SRLOCJ2024-10-10