FDA.report

Pro-X1

Primary DI
05397283000281
Brand
Pro-X1
Company
X-BOLT ORTHOPEDICS INC.
Model
XBT040150
Device description
Ø4.0mm x 150mm Drill Bit, quick connect (freehand)
Published
2024-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05397283000281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05397283000281053972830002815397283000281

GMDN Terms

TermDefinition
Fluted surgical drill bit, single-useA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Device Sizes

TypeValueUnit
Length150Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
119116284
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05397283000007Pro-X1XNI-100-X2024-08-27
05397283000014Pro-X1XNI-200-Y2024-08-27
05397283000021Pro-X1XNI-0022024-08-27
05397283000038Pro-X1XNI-0032024-08-27
05397283000045Pro-X1XNI-0042024-08-27
05397283000052Pro-X1XNI-0052024-08-27
05397283000069Pro-X1XNI-0062024-08-27
05397283000076Pro-X1XNI-0072024-08-27
05397283000083Pro-X1XNI-0082024-08-27
05397283000090Pro-X1XNI-0092024-08-27
05397283000113Pro-X1XNI-0122024-08-27
05397283000120Pro-X1XNI-0142024-08-27
05397283000137Pro-X1XNI-0152024-08-27
05397283000144Pro-X1XNI-0162024-08-27
05397283000168Pro-X1XNI-0182024-08-27
05397283000175Pro-X1XNI-0192024-08-27
05397283000182Pro-X1XNI-0202024-08-27
05397283000199Pro-X1XNI-0212024-08-27
05397283000205Pro-X1XNI-0222024-08-27
05397283000212Pro-X1XNI-0232024-08-27

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