FDA.report

BIOPSYBELL

Primary DI
08033860023065
Brand
BIOPSYBELL
Company
BIOPSYBELL SRL
Model
KYPHOKIT DRILL
Catalog number
KK11-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
08033860023065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033860023065080338600230658033860023065

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

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08033860021641SOMATEXSOMACORE VERIFY900390-US2016-08-01
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08033860021689SOMATEXSOMACORE VERIFY900400-US2016-08-01
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08033860021788SOMATEXSOMACORE VERIFY S900480-US2016-08-01
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08033860021849SOMATEXSOMACORE VERIFY S900500-US2016-08-01
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08033860034764BIOPSYBELLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCARESWTR1112C-US2020-06-12
08033860034771BIOPSYBELLRENOVA SPINE KYPHOPLASTY DRILLRESDRI1112C-US2020-06-12
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08033860037314BIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVELRESWBTR1112C-US2022-09-28
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