FDA.reportPublic FDA data

Bone Filler Kit

Primary DI
00815212021404
Brand
Bone Filler Kit
Company
Izi Medical Products, LLC
Model
G80005
Catalog number
G80005
Published
2016-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument
NDNCement, Bone, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2
NDNCement, Bone, VertebroplastyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022074000
K103433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022074000SPHERZI.Z.I. Corp.2002-08-13HAW
K103433000F20Teknimed, S.A.2011-01-03NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815212021404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212021404008152120214048152120214040815212021404

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic image marker, manualAn object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. It can be positioned either on a patient's body, or next to a patient, or be affixed to the film cassette or holder. It is made from materials compatible with the imaging system with which it is intended to be used. Typically used to imprint information on the images related to image acquisition parameters and/or patient identification, and to record anatomical information.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933506164
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B8870010690X-MARK Ultra0010690010692022-06-17
EIBA10010X-Mark100110012016-09-23
EIBA10020X-Mark100210022016-09-23
EIBA10070X-MArk100710072016-09-23
EIBA10080X-Mark100810082016-09-23
EIBA10090X-Mark100910092016-09-23
EIBA10210X-Mark102110212016-09-23
EIBA10220X-Mark102210222016-09-23
EIBA10230X-Mark102310232016-09-23
EIBA10270X-Mark102710272016-09-23
EIBA10280X-Mark102810282016-09-23
EIBA10290X-Mark102910292016-09-23
EIBA10400X-Mark104010402017-03-16
EIBA10410X-Mark104110412016-09-23
EIBA10420X-Mark104210422016-09-23
EIBA10470X-Mark104710472016-09-23
EIBA10600X-Mark Ultra106010602016-09-23
EIBA10610X-Mark Ultra106110612016-09-23
EIBA10620X-Mark Ultra106210622016-09-23
EIBA10670X-Mark Ultra106710672016-09-23

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Primary DI, Brand, Company table
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