FDA.report

Pro-X1

Primary DI
05397283000236
Brand
Pro-X1
Company
X-BOLT ORTHOPEDICS INC.
Model
XNI-025
Device description
Stealth Palm Screwdriver Handle
Published
2024-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05397283000236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05397283000236053972830002365397283000236

GMDN Terms

TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
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
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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00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
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00888867529076Arthrex®ARTHREX, INC.HSB2026-03-16
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