FDA.reportPublic FDA data

Keos Lumbar Case/Caddy

Primary DI
B0842000203000
Brand
Keos Lumbar Case/Caddy
Company
KEOS
Model
Auxiliary Case, w/ Lid
Catalog number
200-02-0300
Published
2023-01-30
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
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0842000203000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080551837
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
true
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 DIBrandModelCatalogPublished
B0842000200000Keos Lumbar Case/CaddyImplant Case, Lumbar IBFD System, w/ Lid200-02-00002023-01-30
B0842000200100Keos Lumbar Case/CaddyInstrument Case, Lumbar IBFD System, w/ Lid200-02-00102023-01-30
B0842000200210Keos Lumbar Case/CaddyLid, Lumbar IBFD System200-02-00212023-01-30
B0842000201000Keos Lumbar Case/CaddyCaddy Assy, 23L x 8W, Straight, PEEK200-02-01002023-01-30
B0842000201010Keos Lumbar Case/CaddyCaddy Assy, 23L x 10W, Straight, PEEK200-02-01012023-01-30
B0842000201020Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Straight, PEEK200-02-01022023-01-30
B0842000201030Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Curved, PEEK200-02-01032023-01-30
B0842000201040Keos Lumbar Case/CaddyCaddy Assy, 23L x 8W, Straight, PEEK HA-Enhanced200-02-01042023-01-30
B0842000201050Keos Lumbar Case/CaddyCaddy Assy, 23L x 10W, Straight, PEEK HA-Enhanced200-02-01052023-01-30
B0842000201060Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Straight, PEEK HA-Enhanced200-02-01062023-01-30
B0842000201070Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Curved, PEEK HA-Enhanced200-02-01072023-01-30
B0842000201510Keos Lumbar Case/CaddyCaddy Lid, PEEK200-02-01512023-01-30
B0842000201530Keos Lumbar Case/CaddyCaddy Lid, PEEK HA-Enhanced200-02-01532023-01-30
B0842000202000Keos Lumbar Case/CaddyInstrument Case, Limited Release MPE, w/ Lid200-02-02002023-01-30
B0842002400000Keos Lumbar InstrumentT-Handle, QC, 1/4" Square Adapter200-24-00002023-01-30
B0842002600000Keos Lumbar InstrumentInsertion Handle, Threaded200-26-00002023-01-30
B0842002600100Keos Lumbar InstrumentInsertion Rod, Threaded200-26-00102023-01-30
B0842002700000Keos Lumbar InstrumentInsertion Handle, Clamp200-27-00002023-01-30
B0842002700020Keos Lumbar InstrumentAttachment Knob, Insertion Handle, Clamp200-27-00022023-01-30
B0842002700100Keos Lumbar InstrumentInsertion Fork, Insertion Handle, Clamp200-27-00102023-01-30

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