FDA.reportPublic FDA data

NOVAE

Primary DI
03662200013142
Brand
NOVAE
Company
SOC ETUDES RECHERCHES FABRICATION
Model
FT 69
Published
2022-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662200013142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662200013142036622000131423662200013142

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular orthopaedic reamerAn orthopaedic surgical instrument designed to cut and resurface with precision the acetabulum for the acceptance of the acetabular component of a hip joint prosthesis. The device is designed with a hemispherical shell with an abrasive outer surface as the cutting head that is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
282651413
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662200033126Trays associated with hip instrumentsRA999900622024-09-17
03662200005796CI ECI 41/22,2 E2015-09-01
03662200005802CI ECI 43/22,2 E2015-09-01
03662200005819CI ECI 45/22,2 E2015-09-01
03662200005826CI ECI 47/22,2 E2015-09-01
03662200005833CI ECI 49/22,2 E2015-09-01
03662200005840CI ECI 51/22,2 E2015-09-01
03662200005857CI ECI 53/22,2 E2015-09-01
03662200005864CI ECI 55/22,2 E2015-09-01
03662200005871CI ECI 57/22,2 E2015-09-01
03662200005888CI ECI 59/22,2 E2015-09-01
03662200005895CI ECI 61/22,2 E2015-09-01
03662200005901CI ECI 63/22,2 E2015-09-01
03662200005918CI ECI 65/22,2 E2015-09-01
03662200005925CI ECI 67/22,2 E2015-09-01
03662200005932CI ECI 69/22,2 E2015-09-01
03662200005963CI ECI 47/28 E2015-09-01
03662200005970CI ECI 49/28 E2015-09-01
03662200005987CI ECI 51/28 E2015-09-01
03662200005994CI ECI 53/28 E2015-09-01

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