FDA.report

BIOPSYBELL

Primary DI
08033860034733
Brand
BIOPSYBELL
Company
BIOPSYBELL SRL
Model
CIFOPACK DRILL
Catalog number
KPA11-DRI
Device description
KYPHOPLASTY DRILL
Published
2023-06-19
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
HXYBrace, Drill

Product Code Classifications

CodeDeviceSpecialtyClass
HXYBrace, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033860034733PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorEAN-13Conversion note
08033860034733140803386003473308033860034733Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00.

GMDN Terms

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.

Device Sizes

TypeValueUnit
Needle Gauge11Gauge
Outer Diameter3Millimeter

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
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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04049197096812RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-16
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04049197187848RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-06-28
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M73910290060TransFasten-LSF, Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
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M73910290140TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
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