FDA.reportPublic FDA data

Pro-X1

Primary DI
05397283000038
Brand
Pro-X1
Company
X-BOLT ORTHOPEDICS INC.
Model
XNI-003
Device description
T-Handle Quick Fit Jacobs Chuck
Published
2024-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05397283000038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05397283000038053972830000385397283000038

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill chuckA device designed to grip a cutting tool (normally a drill bit or other rotational cutting tool) using three adjustable jaws that are geared to be manually closed concentrically upon the cutting tool. It is attached (locked) to a surgical drilling machine which is usually powered, but may be manual. A special key is often used to close and tighten the jaws. Commonly known as a Jacobs chuck, it is typically made of high-grade stainless steel to resist the corrosive effects of sterilization processes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119116284
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05397283000311Pro-X1XBT0500302024-08-27
05397283000328Pro-X1XBT0500352024-08-27
05397283000335Pro-X1XBT0500402024-08-27
05397283000342Pro-X1XBT0500452024-08-27
05397283000359Pro-X1XBT0500502024-08-27
05397283000366Pro-X1XBT0500552024-08-27
05397283000373Pro-X1XBT1050802024-08-27
05397283000380Pro-X1XBT1050852024-08-27
05397283000397Pro-X1XBT1050902024-08-27
05397283000403Pro-X1XBT1050952024-08-27
05397283000410Pro-X1XBT1051002024-08-27
05397283000427Pro-X1XBT1051052024-08-27
05397283000434Pro-X1XBT1051102024-08-27
05397283000441Pro-X1XBT1051152024-08-27
05397283000458Pro-X1XBT1051202024-08-27
05397283000465Pro-X1XBT1051252024-08-27
05397283000472Pro-X1XBT1101952024-08-27
05397283000489Pro-X1XBT110300L2024-08-27
05397283000496Pro-X1XBT110300R2024-08-27
05397283000502Pro-X1XBT110325L2024-08-27

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Primary DI, Brand, Company table
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