FDA.reportPublic FDA data

CANNULATED PEDIGUARD

Primary DI
03662674000105
Brand
CANNULATED PEDIGUARD
Company
SPINEGUARD
Model
CANNULATED PEDIGUARD STARTER STYLET - TROCAR
Catalog number
P2ST1060
Published
2018-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662674000105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662674000105036626740001053662674000105

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33(0)145184519qara@spineguard.com

Regulatory Flags#

DUNS number
260589566
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662674000570PEDIGUARD THREADED DSG Pin 6D1PU00062025-09-29
03662674000594CANNULATED PEDIGUARDNeedle XS, Trocar, 130mmP2ND22012025-09-18
03662674000495PediGuard DSG ConnectPediGuard DSG Connect Ø2.5P1-AU5132025-09-17
03662674000501PediGuard DSG ConnectPediGuard DSG Connect CurvP1-AU5502025-09-17
03662674000518PediGuard DSG ConnectPediGuard DSG Connect Ø2.5 XSP1-AU5142025-09-17
03662674000525PediGuard DSG ConnectPediGuard DSG Connect Curv XSP1-AU5502025-09-17
03662674000556PEDIGUARD THREADED DSG Threaded Shaft L Ø5mmD1TA00202025-09-17
03662674000563PEDIGUARD THREADED DSG Threaded Shaft L Ø4.5mmD1TA00212025-09-17
03662674000471PediGuard DSG ConnectPediGuard DSG Connect Ø4.0P1-AU5112025-08-28
03662674000488PediGuard DSG ConnectPediGuard DSG Connect Ø3.2P1-AU5122025-08-28
03662674000006PEDIGUARD CLASSICPEDIGUARD TRI TIP 4.0mmP1-AU4112016-06-28
03662674000013PEDIGUARD CLASSICPEDIGUARD TRI TIP 3.2mmP1-AU4122016-08-22
03662674000020PEDIGUARD CLASSICPEDIGUARD TRI TIP 2.5mmP1-AU4132016-08-29
03662674000037PEDIGUARD CLASSICPEDIGUARD TRI TIP 2.5mm XSP1-AU4142016-08-29
03662674000044PEDIGUARD CURVPEDIGUARD CURVP1-AU4502016-08-29
03662674000051PEDIGUARD CURVPEDIGUARD CURV XSP1-AU4512016-08-29
03662674000068CANNULATED PEDIGUARDCANNULATED PEDIGUARD HANDLEP2HE10002016-08-29
03662674000075CANNULATED PEDIGUARDCANNULATED PEDIGUARD NEEDLE 1P2ND10012016-08-29
03662674000112CANNULATED PEDIGUARDCANNULATED PEDIGUARD NEEDLE 2P2ND10022016-08-29
03662674000129CANNULATED PEDIGUARDCANNULATED PEDIGUARD NEEDLE TROCAR 120mmP2ND11012016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700423Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700843Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700850Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700874Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700881Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700997Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701017Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701031Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701048Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701062Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701086Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701093Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701109Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701116ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701123ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701130ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701147ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701154ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701161ArtiSential Precise DissectorLIVSMEDMDM2026-04-29