FDA.report

BIOPSYBELL

Primary DI
08033860019013
Brand
BIOPSYBELL
Company
BIOPSYBELL SRL
Model
RENOVA SPINE FAST ACCESS SYSTEM
Catalog number
RES1112001V
Device description
KYPHOPLASTY FAST ACCESS BONE ACCESS KIT
Published
2023-06-16
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
OCJSpinal Channeling Instrument, Vertebroplasty

Product Code Classifications

CodeDeviceSpecialtyClass
OCJSpinal Channeling Instrument, VertebroplastyOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033860019013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033860019013080338600190138033860019013

GMDN Terms

TermDefinition
Bone access channel kitA collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. 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

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08033860021641SOMATEXSOMACORE VERIFY900390-US2016-08-01
08033860021665SOMATEXSOMACORE VERIFY900392-US2016-08-01
08033860021689SOMATEXSOMACORE VERIFY900400-US2016-08-01
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08033860021726SOMATEXSOMACORE VERIFY900404-US2016-08-01
08033860021740SOMATEXSOMACORE VERIFY900410-US2016-08-01
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08033860021788SOMATEXSOMACORE VERIFY S900480-US2016-08-01
08033860021801SOMATEXSOMACORE VERIFY S900490-US2016-08-01
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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
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