FDA.reportPublic FDA data

Vertebroplasty Needle Kit, 12G, Diamond Tip

Primary DI
04260277175597
Brand
Vertebroplasty Needle Kit, 12G, Diamond Tip
Company
Möller Medical GmbH
Model
10001543US
Catalog number
03.702.220S
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
04260277175597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277175597042602771755974260277175597

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260277172831Breast localisation needleBLM-1110-20-00302018-08-17
04260277172848Breast localisation needleBLM-1110-20-00502018-08-17
04260277172862Breast localisation needleBLM-1110-20-01002018-12-10
04260277172855Breast localisation needleBLM-1110-20-00752018-08-17
04260277172879Breast localisation needleBLM-1110-20-01252018-08-17
04260277172930Breast localisation needleBLM-1120-20-00302018-08-17
04260277172947Breast localisation needleBLM-1120-20-00502018-08-17
04260277172954Breast localisation needleBLM-1120-20-00752018-08-17
04260277172961Breast localisation needleBLM-1120-20-01002018-08-17
04260277172978Breast localisation needleBLM-1120-20-01252018-08-17
04260277173036Breast localisation needleBLM-1130-20-00302018-08-17
04260277173043Breast localisation needleBLM-1130-20-00502018-08-17
04260277173050Breast localisation needleBLM-1130-20-00752018-08-17
04260277173067Breast localisation needleBLM-1130-20-01002018-08-17
04260277173074Breast localisation needleBLM-1130-20-01252018-08-17
04260277173654Breast localisation needleBLM-1125-20-00302018-08-17
04260277173661Breast localisation needleBLM-1125-20-00502018-08-17
04260277173678Breast localisation needleBLM-1125-20-00752018-08-17
04260277173685Breast localisation needleBLM-1125-20-01002018-08-17
04260277173692Breast localisation needleBLM-1125-20-01252018-08-17

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Primary DI, Brand, Company table
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10886982350688VOLTSynthes GmbHFZX2026-09-25
10886982351098VOLTSynthes GmbHFZX2026-09-25
10886982351104VOLTSynthes GmbHFZX2026-09-25
10886982351111VOLTSynthes GmbHFZX2026-09-25
10886982351128VOLTSynthes GmbHFZX2026-09-25
10886982351135VOLTSynthes GmbHFZX2026-09-25
10886982351142VOLTSynthes GmbHFZX2026-09-25
10886982351692VOLTSynthes GmbHFZX2026-09-25
10886982357182VOLTSynthes GmbHFZX2026-09-25
00190776432164MillenniumAvalign Technologies, Inc.FZX2026-09-22
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00190776423896MillenniumAvalign Technologies, Inc.FZX2026-08-26
10886982362988NASynthes GmbHFZX2026-08-26
10886982362995NASynthes GmbHFZX2026-08-26
10886982363008NASynthes GmbHFZX2026-08-26
10886982363015NASynthes GmbHFZX2026-08-26
008890247114712.9 JuggerKnot Self-Punching ObturatorZimmer, Inc.FZX2026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaZimmer, Inc.FZX2026-08-25
00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
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