CosmoLock DR-K01-0028

GUDID B073DRK0100280

Tab Breaker, Single Sided, Cosmolock MIS

Kalitec Direct LLC

Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter
Primary Device IDB073DRK0100280
NIH Device Record Key698ba3f1-8cf2-4818-a201-01762479fd61
Commercial Distribution StatusIn Commercial Distribution
Brand NameCosmoLock
Version Model NumberDR-K01-0028
Catalog NumberDR-K01-0028
Company DUNS041956211
Company NameKalitec Direct LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]
HIBCCB073DRK0100280 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


[B073DRK0100280]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [CosmoLock]

B07311K0361090Distractor, Fixed Tip
B07311K0361080Compressor, Fixed Tip
B07310K0197010Assembly, Compressor - Distractor Lever, Full MIS
B07310K0123000Recovery Tube, MIS
B07311K1100140Implant Tray, Cosmolock, Arcamed
B07311K1100110Tray Insert 4, Cosmolock, Arcamed
B07311K1100100Tray Insert 3, Cosmolock, Arcamed
B07311K1100090Tray Insert 2, Cosmolock, Arcamed
B07311K1100080Tray Insert 1, Cosmolock, Arcamed
B07311K0600130Tray Insert 3, Cosmolock Deformity
B07311K0600120Tray Insert 5, Cosmolock Deformity
B07310K0690140Tray Insert, MIS Lumbar Instrument 3
B0731010K0690150Tray Insert, MIS Lumbar Instrument 4
B07311K0170200Handheld Fascia Dilator
B07311K0140120Guide, Anti-Splay
B07311K0130120Segmental Rod Reducer Driver
B07311K0130110Segmental Rod Reducer, Slim, Assembly
B07311K0130100Segmental Rod Reducer Assembly
B07311K0100210Caddie Lid, Rods, 5.5mm
B07311K0100200Caddie, Rods, 5.5mm Assembly
B07311K0100060Tray Insert, Lumbar Screws, 10 x 10 Assembly
B07311K1430210Rod Template, 500mm
B07311K1430200Rod Template, 250mm
B07311K0316920Probe, 1.75" Egg, Steffee, Long, Straight, Impact
B07311K0150050Sizer, Fixed Crosslink Assembly
B07311K0120220Assembly, Screwdriver, Extended Tab
B07311K0120210Assembly, Screwdriver, Extended Tab, Cannulated, Lockable
B07311K0120150Assembly, Screwdriver, Polyaxial, Lockable
B073DRK0100280Tab Breaker, Single Sided, Cosmolock MIS

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