FDA.report

Kalitec Disc Prep

Primary DI
B07319K0160410
Brand
Kalitec Disc Prep
Company
Kalitec Direct LLC
Model
19-K01-6041
Catalog number
19-K01-6041
Device description
Curette, Left Angle, #5
Published
2019-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HTFCurette

Product Code Classifications

CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B07319K0160410PrimaryHIBCC0

GMDN Terms

TermDefinition
Spinal curetteA hand-held, sterile surgical instrument used to scrape and score the cancellous vertebral bone of the spine, typically during a percutanous, minimally-invasive procedure. It consists of a long, thin, metal shaft that terminates distally in a mushroom-like cutting head that can be set at alternative angles (up to ninety degrees). The device enables a smooth scoring action for the creation of grooves or channels, and is typically used as an adjunct device in the treatment of vertebral compression fractures (VCFs) during kyphoplasty. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
041956211
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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