FDA.report

BIOPSYBELL

Primary DI
08033860023102
Brand
BIOPSYBELL
Company
BIOPSYBELL SRL
Model
KYPHOKIT BONE FILLER
Catalog number
KK11-FIL
Device description
KYPHOPLASTY BONE FILLER KIT
Published
2023-06-15
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

Related Records

Contact Domains

Product Codes

CodeName
OARInjector, Vertebroplasty (Does Not Contain Cement)

Product Code Classifications

CodeDeviceSpecialtyClass
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033860023102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033860023102080338600231028033860023102

GMDN Terms

TermDefinition
Vertebral body cement cannulaA sterile, manual, tubular device designed to create a percutaneous access channel into a vertebral body prior to and during injection of orthopaedic cement into the vertebral body during kyphoplasty. It is typically inserted under fluoroscopic guidance to treat a patient diagnosed with vertebral compression fractures (VCFs) in the lumbar or thoracic region of the spine. The device is typically made of stainless steel with an attached plastic handle and available in a kit of several equal size cannulae (e.g., 3 or 6) to provide access to one or more sites of intervention. This is a single-use device.

Device Sizes

TypeValueUnit
Needle Gauge11Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
+39053527850support@biopsybell.it

Regulatory Flags

DUNS number
438746708
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08033860021603SOMATEXSOMACORE VERIFY900380-US2016-08-01
08033860021627SOMATEXSOMACORE VERIFY900382-US2016-08-01
08033860021641SOMATEXSOMACORE VERIFY900390-US2016-08-01
08033860021665SOMATEXSOMACORE VERIFY900392-US2016-08-01
08033860021689SOMATEXSOMACORE VERIFY900400-US2016-08-01
08033860021702SOMATEXSOMACORE VERIFY900402-US2016-08-01
08033860021726SOMATEXSOMACORE VERIFY900404-US2016-08-01
08033860021740SOMATEXSOMACORE VERIFY900410-US2016-08-01
08033860021764SOMATEXSOMACORE VERIFY900412-US2016-08-01
08033860021788SOMATEXSOMACORE VERIFY S900480-US2016-08-01
08033860021801SOMATEXSOMACORE VERIFY S900490-US2016-08-01
08033860021825SOMATEXSOMACORE VERIFY S900492-US2016-08-01
08033860021849SOMATEXSOMACORE VERIFY S900500-US2016-08-01
08033860021863SOMATEXSOMACORE VERIFY S900502-US2016-08-01
08033860034757BIOPSYBELLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVELRESWB1112C-US2020-06-12
08033860034764BIOPSYBELLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCARESWTR1112C-US2020-06-12
08033860034771BIOPSYBELLRENOVA SPINE KYPHOPLASTY DRILLRESDRI1112C-US2020-06-12
08033860034818BIOPSYBELLRENOVA SPINE BONE FILLERRESFIL1112C1-US2020-06-12
08033860037314BIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVELRESWBTR1112C-US2022-09-28
08033860043643BIOPSYBELLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVELRESWB0812C-US2024-02-23

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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
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08033860015435BIOPSYBELLBIOPSYBELL SRLOAR2023-06-16
08033860017521BIOPSYBELLBIOPSYBELL SRLOAR2023-06-16
08033860022419BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860026592BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
08033860034740BIOPSYBELLBIOPSYBELL SRLOAR2023-06-15
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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
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