FDA.reportPublic FDA data

VSP System, VSP Cranial

Primary DI
00816847021326
Brand
VSP System, VSP Cranial
Company
3D SYSTEMS, INC.
Model
Drill Guide (1.1 mm & 2.3 mm Screws)
Device description
Reusable accessory drill guide
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDriver, Wire, And Bone Drill, Manual
LLZSystem, Image Processing, Radiological
PPTCranial Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
LLZSystem, Image Processing, RadiologicalRadiology2
PPTCranial Surgical Planning And Instrument GuidesNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816847021326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847021326008168470213268168470213260816847021326

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8446431001Golden-CustomerService@3DSystems.Com

Regulatory Flags#

DUNS number
085049749
Device count
1
Lot or batch
true
Sterilization required before use
true

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00816847022699Salto Talaris Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
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00816847022729Cadence Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
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