Home GUDID B07319K0160110 Kalitec Disc Prep
Primary DI B07319K0160110
Brand Kalitec Disc Prep
Company Kalitec Direct LLC
Model 19-K01-6011
Catalog number 19-K01-6011
Device description Currette, Straight, #5
Published 2019-12-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FSM Tray, Surgical, Instrument HTF Curette
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1 HTF Curette General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B07319K0160110 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Spinal curette A 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 table 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 Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B07315K0112220 NIDO Pedicle Screw System 15-K01-1222 15-K01-1222 2025-03-19 B07315K0112300 NIDO Pedicle Screw System 15-K01-1230 15-K01-1230 2025-03-19 B07315CLA50100 NIDO Pedicle Screw System 15-CLA-5010 15-CLA-5010 2024-09-19 B07315CLA51100 NIDO Pedicle Screw System 15-CLA-5110 15-CLA-5110 2024-09-19 B07330TNS27070 Navagio Lumbar Cage 30-TNS-2707 30-TNS-2707 2024-08-12 B07330TTS27070 Navagio Lumbar Cage 30-TTS-2707 30-TTS-2707 2024-08-12 B07311K0130400 Cosmolock 11-K01-3040 11-K01-3040 2024-06-20 B07315K0120120 NIDO Pedicle Screw System 15-K01-2012 15-K01-2012 2024-05-31 B07315K0120100 NIDO Pedicle Screw System 15-K01-2010 15-K01-2010 2024-05-02 B07315K0170000 NIDO Pedicle Screw System 15-K01-7000 15-K01-7000 2024-03-01 B07310BRS02300 Cosmolock 10-BRS-0230 10-BRS-0230 2024-01-16 B07315BCC05000 NIDO Pedicle Screw System 15-BCC-0500 15-BCC-0500 2023-10-06 B07315BCC05050 NIDO Pedicle Screw System 15-BCC-0505 15-BCC-0505 2023-10-06 B07315BCC05100 NIDO Pedicle Screw System 15-BCC-0510 15-BCC-0510 2023-10-06 B07315BCC05150 NIDO Pedicle Screw System 15-BCC-0515 15-BCC-0515 2023-10-06 B07315BCC05250 NIDO Pedicle Screw System 15-BCC-0525 15-BCC-0525 2023-10-06 B07315BCC05300 NIDO Pedicle Screw System 15-BCC-0530 15-BCC-0530 2023-10-06 B07315BCC05350 NIDO Pedicle Screw System 15-BCC-0535 15-BCC-0535 2023-10-06 B07315BCC05400 NIDO Pedicle Screw System 15-BCC-0540 15-BCC-0540 2023-10-06 B07315BCC05450 NIDO Pedicle Screw System 15-BCC-0545 15-BCC-0545 2023-10-06
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