FDA.reportPublic FDA data

BIOPSYBELL

Primary DI
08033860044954
Brand
BIOPSYBELL
Company
BIOPSYBELL SRL
Model
OSTEOPEARL™ BONE FILLER 8G
Catalog number
100.438
Device description
OsteoPearl™ Bone Filler, 8G Orthopedic procedure with Biological Allograft Chain
Published
2024-06-12
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033860044961PackageGS110In Commercial Distribution
08033860044954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033860044961080338600449618033860044961
08033860044954080338600449548033860044954

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft delivery kitA collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length182Millimeter
Needle Gauge8Gauge

Contacts#

Phone, Email table
PhoneEmail
+39053527850support@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
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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

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