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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143159000Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XSSpineguard S.A.2015-01-23PDQ

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 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-5 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
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
03662674000075CANNULATED PEDIGUARDCANNULATED PEDIGUARD NEEDLE 1P2ND10012016-08-29
03662674000105CANNULATED PEDIGUARDCANNULATED PEDIGUARD STARTER STYLET - TROCARP2ST10602018-10-22
03662674000112CANNULATED PEDIGUARDCANNULATED PEDIGUARD NEEDLE 2P2ND10022016-08-29
03662674000129CANNULATED PEDIGUARDCANNULATED PEDIGUARD NEEDLE TROCAR 120mmP2ND11012016-08-29

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