FDA.reportPublic FDA data

CANNULATED PEDIGUARD

Primary DI
03662674000068
Brand
CANNULATED PEDIGUARD
Company
SPINEGUARD
Model
CANNULATED PEDIGUARD HANDLE
Catalog number
P2HE1000
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve
PDQNeurosurgical Nerve Locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662674000068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662674000068036626740000683662674000068

GMDN Terms#

Term, Definition table
TermDefinition
Bone access cannulaA sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
260589566
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662674000525PediGuard DSG ConnectPediGuard DSG Connect Curv XSP1-AU5512025-09-17
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
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
03662674000075CANNULATED PEDIGUARDCANNULATED PEDIGUARD NEEDLE 1P2ND10012016-08-29

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