FDA.reportPublic FDA data

VSP System, VSP Cranial

Primary DI
00816847021340
Brand
VSP System, VSP Cranial
Company
3D SYSTEMS, INC.
Model
Metal Slot (35mm)
Device description
Reusable accessory Cutting insert
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
00816847021340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847021340008168470213408168470213400816847021340

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guideA non-sterile surgical instrument intended to be attached to a portion of bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure to outline the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Millimeter

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816847022859VSP PEEKHost Skull Model2025-11-10
00816847022736Salto Talaris Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022743Salto Talaris Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022750Salto Talaris Flat Cut Total Ankle SystemAnatomical Model2025-01-10
00816847022767Cadence Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022774Cadence Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022781Cadence Flat Cut Total Ankle SystemAnatomical model2025-01-10
00816847022637Cadence Chamfer Cut Total Ankle SystemAnatomical model2024-09-12
00816847022651Salto Talaris Chamfer Cut Total Ankle SystemAnatomical Model2024-09-12
00816847022675VSP PEEKCranial Implant2024-09-12
00816847022699Salto Talaris Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022712Cadence Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022729Cadence Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022798Vantage 3D PSITibia Cutting Guide2024-08-05
00816847022804Vantage 3D PSITalus Cutting Guide2024-08-05
00816847022811Vantage 3D PSIAnatomical Model2024-08-05
00816847022828Vantage 3D+ PSITibia Cutting Guide2024-08-05
00816847022835Vantage 3D+ PSITalus Cutting Guide2024-08-05
00816847022842Vantage 3D+ PSIAnatomical Model2024-08-05

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