FDA.reportPublic FDA data

PediGuard DSG Connect

Primary DI
03662674000471
Brand
PediGuard DSG Connect
Company
SPINEGUARD
Model
PediGuard DSG Connect Ø4.0
Catalog number
P1-AU511
Published
2025-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve
HBGDrills, Burrs, Trephines & Accessories (Manual)
PDQNeurosurgical Nerve Locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
HBGDrills, Burrs, Trephines & Accessories (Manual)Neurology2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201454000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201454000DSG Connect TechnologySpineguard S.A.2021-02-10PDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662674000471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662674000471036626740004713662674000471

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length55Millimeter
Outer Diameter4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33145184519qara@spineguard.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662674000549DSG ConnectDSG Connect AppD1SW00012026-10-22
03662674000525PediGuard DSG ConnectPediGuard DSG Connect Curv XSP1-AU5512025-09-17
03662674000068CANNULATED PEDIGUARDCANNULATED PEDIGUARD HANDLEP2HE10002016-08-29
03662674000099CANNULATED PEDIGUARDCANNULATED PEDIGUARD STARTER STYLET - BEVELP2ST10502018-10-22
03662674000174PEDIGUARD THREADEDDSG Pin 1D1PU00012016-08-29
03662674000389PEDIGUARD THREADEDSTARTER Pin 5D1SP00052016-12-26
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
03662674000556PEDIGUARD THREADED DSG Threaded Shaft L Ø5mmD1TA00202025-09-17
03662674000563PEDIGUARD THREADED DSG Threaded Shaft L Ø4.5mmD1TA00212025-09-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662674000549DSG ConnectSPINEGUARDPDQ2026-10-22
03662674000549DSG ConnectSPINEGUARDETN2026-10-22
00860010951705NeuralytixNEURALYTIX, LLCPDQ2026-10-19
00860010951705NeuralytixNEURALYTIX, LLCETN2026-10-19
00810161901562EARP NERVE CUFF ELECTRODE, 5MMRETROPSOAS TECHNOLOGIES, LLCETN2026-10-16
00810161901548EARP NERVE CUFF ELECTRODE, 3MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901555EARP NERVE CUFF ELECTRODE, 4MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901579EARP NERVE CUFF ELECTRODE, 6MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
04250307604388N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHETN2026-10-01
00763000843908NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
10840113234728BovieASPEN SURGICAL PRODUCTS, INC.ETN2026-08-17
00887517127693MaXcessNuvasive, Inc.ETN2026-07-27
00763000821777NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821784NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821791NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821807NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821814NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
M68980801D160Fresh Whole Blood Donor Transfusion SetSafeguard US Operating, LLCPDQ2026-05-04
00887517413673MAS PLIFNuvasive, Inc.ETN2026-04-25
00199150037407NIM™MEDTRONIC XOMED, INC.ETN2026-03-29
03662674000525PediGuard DSG ConnectSPINEGUARDPDQ2025-09-17
03662674000525PediGuard DSG ConnectSPINEGUARDETN2025-09-17
03662674000525PediGuard DSG ConnectSPINEGUARDHBG2025-09-17