FDA.reportPublic FDA data

Pro-X1

Primary DI
05397283000007
Brand
Pro-X1
Company
X-BOLT ORTHOPEDICS INC.
Model
XNI-100-X
Device description
Set 'X' Instrument Tray (Fully Kitted)
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
05397283000007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05397283000007053972830000075397283000007

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
119116284
Device count
1
Lot or batch
true
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982471415AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
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00193982471453AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471477AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471491AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471514AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471538AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471767AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471781AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471804AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471828AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471842AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471866AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471880AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472115AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472139AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472153AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472177AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472191AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472214AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472238AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473822AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473846AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473860AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473884AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473907AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473921AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473945AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982474171AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982474195AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14