FDA.report

FO NX Nail System

Primary DI
09353903006459
Brand
FO NX Nail System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
APN000239
Catalog number
NXDL(c)-175/1
Device description
1.75 Thermally Hardened Cannulated Drill Bit 1/pkg
Published
2022-10-21
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
true

Related Records

Product Codes

CodeName
HTWBit, Drill

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09353903006459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09353903006459093539030064599353903006459

GMDN Terms

TermDefinition
Cannulated surgical drill bit, single-use, non-sterileA non-sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
744008914
Device count
1
DM exempt
true
Premarket exempt
false
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 DIBrandModelCatalogPublished
09353903000006FO Micro Screw SystemMSCP-0615MSCP-0615/12019-01-21
09353903000013FO Micro Screw SystemMSCP-0715MSCP-0715/12019-01-21
09353903000020FO Micro Screw SystemMSCP-0815MSCP-0815/12019-01-21
09353903000037FO Micro Screw SystemMSCP-0915MSCP-0915/12019-01-21
09353903000044FO Micro Screw SystemMSCP-1015MSCP-1015/12019-01-21
09353903000051FO Micro Screw SystemMSCP-1115MSCP-1115/12019-01-21
09353903000068FO Micro Screw SystemMSCP-1215MSCP-1215/12019-01-21
09353903000075FO Micro Screw SystemMSCP-1315MSCP-1315/12019-01-21
09353903000082FO Micro Screw SystemMSCP-1415MSCP-1415/12019-01-21
09353903000099FO Micro Screw SystemMSCP-1515MSCP-1515/12019-01-21
09353903000105FO Micro Screw SystemMSCP-1615MSCP-1615/12019-01-21
09353903000112FO Micro Screw SystemMSCP-0620MSCP-0620/12019-01-21
09353903000129FO Micro Screw SystemMSCP-0720MSCP-0720/12019-01-21
09353903000136FO Micro Screw SystemMSCP-0820MSCP-0820/12019-01-21
09353903000143FO Micro Screw SystemMSCP-0920MSCP-0920/12019-01-21
09353903000150FO Micro Screw SystemMSCP-1020MSCP-1020/12019-01-21
09353903000167FO Micro Screw SystemMSCP-1120MSCP-1120/12019-01-21
09353903000174FO Micro Screw SystemMSCP-1220MSCP-1220/12019-01-21
09353903000181FO Micro Screw SystemMSCP-1320MSCP-1320/12019-01-21
09353903000198FO Micro Screw SystemMSCP-1420MSCP-1420/12019-01-21

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