FDA.report

AVAflex

Primary DI
10885403223259
Brand
AVAflex
Company
CAREFUSION 2200, INC
Model
AFB1015
Catalog number
AFB1015
Device description
AVAFLEX™ VERTEBRAL BALLOON SYSTEM 10GX15MM
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NDNCement, Bone, Vertebroplasty

Product Code Classifications

CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885403223257PackageGS15Not in Commercial Distribution
10885403223259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088540322325750885403223257
1088540322325910885403223259

GMDN Terms

TermDefinition
Balloon kyphoplasty kitA collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.

Device Sizes

TypeValueUnit
Length15Millimeter
Needle Gauge10Gauge

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
832696038
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true

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