FDA.report

Pro-X1

Primary DI
05397283000199
Brand
Pro-X1
Company
X-BOLT ORTHOPEDICS INC.
Model
XNI-021
Device description
Long Screwdriver Shaft (3.5mm Hex)
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
05397283000199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05397283000199053972830001995397283000199

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
05397283000205Pro-X1XNI-0222024-08-27
05397283000212Pro-X1XNI-0232024-08-27
05397283000229Pro-X1XNI-0242024-08-27

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00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529069Arthrex®ARTHREX, INC.HSB2026-03-16
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