FDA.reportPublic FDA data

Vertebroplasty Needle Kit, 8G, Diamond Tip

Primary DI
04260277175573
Brand
Vertebroplasty Needle Kit, 8G, Diamond Tip
Company
Möller Medical GmbH
Model
10001541US
Catalog number
03.702.216S
Device description
The “Vertebroplasty Needle Kit“, part of the Synthes’ Vertecem / Vertecem V+ System, is a sterile packed kit for Vertebroplasty procedures. The needle kit is to be used in conjunction with PMMA cement and appropriate syringes.
Published
2019-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument
KIHDispenser, Cement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
KIHDispenser, CementOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260277175573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277175573042602771755734260277175573

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral bone biopsy procedure kit, single-useA collection of sterile devices, equipment, and supplies used to obtain a bone specimen from the vertebrae of a patient (the bony segments of the spinal column) for histological analysis. It typically contains a metal cannula which can have various tip designs (e.g., bevelled, pyramidal, scoop-, or diamond-shaped) and stylet(s), a biopsy needle, an obturator, a needle holder, syringes, and connecting tube. The specimen can be used for the detection of cancer, infection, or other bone disorders. The device may also be used for vertebral infusion (e.g., injection of bone cement). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
320405061
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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04260277172831Breast localisation needleBLM-1110-20-00302018-08-17
04260277172848Breast localisation needleBLM-1110-20-00502018-08-17
04260277172862Breast localisation needleBLM-1110-20-01002018-12-10
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