FDA.reportPublic FDA data

Biopsy Kit for 8G Vertebroplasty Needle Kit

Primary DI
04260277175634
Brand
Biopsy Kit for 8G Vertebroplasty Needle Kit
Company
Möller Medical GmbH
Model
10001574US
Catalog number
03.702.222S
Device description
The biopsy kit for the Synthes Vertecem / Vertecem V + system is a sterile packed kit for taking bone biopsies from the vertebral body.
Published
2019-07-04
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
MJGDevice, Percutaneous, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260277175634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277175634042602771756344260277175634

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
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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