FDA.reportPublic FDA data

Keos Anterior Cervical Case/Caddy

Primary DI
B0842020201200
Brand
Keos Anterior Cervical Case/Caddy
Company
KEOS
Model
Caddy Assy, 12D x 14W x 7L, PEEK-HA
Catalog number
202-02-0120
Published
2023-12-14
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

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
B0842020201200PrimaryHIBCC0

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
B084AC1141605000Anterior Cervical IBFD14D x 16W x 05H x 0L, PEEKAC1-141605-002024-01-26
B084AC1141605040Anterior Cervical IBFD14D x 16W x 05H x 4L, PEEKAC1-141605-042024-01-26
B084AC1141606000Anterior Cervical IBFD14D x 16W x 06H x 0L, PEEKAC1-141606-002024-01-26
B084AC1141606040Anterior Cervical IBFD14D x 16W x 06H x 4L, PEEKAC1-141606-042024-01-26
B084AC1141607000Anterior Cervical IBFD14D x 16W x 07H x 0L, PEEKAC1-141607-002024-01-26
B084AC1141607040Anterior Cervical IBFD14D x 16W x 07H x 4L, PEEKAC1-141607-042024-01-26
B084AC1141608000Anterior Cervical IBFD14D x 16W x 08H x 0L, PEEKAC1-141608-002024-01-26
B084AC1141608040Anterior Cervical IBFD14D x 16W x 08H x 4L, PEEKAC1-141608-042024-01-26
B084AC1141609000Anterior Cervical IBFD14D x 16W x 09H x 0L, PEEKAC1-141609-002024-01-26
B084AC1141609040Anterior Cervical IBFD14D x 16W x 09H x 4L, PEEKAC1-141609-042024-01-26
B084AC1141610000Anterior Cervical IBFD14D x 16W x 10H x 0L, PEEKAC1-141610-002024-01-26
B084AC1141610040Anterior Cervical IBFD14D x 16W x 10H x 4L, PEEKAC1-141610-042024-01-26
B084AC1141611000Anterior Cervical IBFD14D x 16W x 11H x 0L, PEEKAC1-141611-002024-01-26
B084AC1141611040Anterior Cervical IBFD14D x 16W x 11H x 4L, PEEKAC1-141611-042024-01-26
B084AC1141612000Anterior Cervical IBFD14D x 16W x 12H x 0L, PEEKAC1-141612-002024-01-26
B084AC1141612040Anterior Cervical IBFD14D x 16W x 12H x 4L, PEEKAC1-141612-042024-01-26
B084AC1121405000Anterior Cervical IBFD12D x 14W x 05H x 0L, PEEKAC1-121405-002024-01-01
B084AC1121405040Anterior Cervical IBFD12D x 14W x 05H x 4L, PEEKAC1-121405-042024-01-01
B084AC1121405070Anterior Cervical IBFD12D x 14W x 05H x 7L, PEEKAC1-121405-072024-01-01
B084AC1121406000Anterior Cervical IBFD12D x 14W x 06H x 0L, PEEKAC1-121406-002024-01-01

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