FDA.reportPublic FDA data

PEDIGUARD THREADED

Primary DI
03662674000259
Brand
PEDIGUARD THREADED
Company
SPINEGUARD
Model
DSG Technology Instrument Set - Base
Catalog number
D1TT1001
Published
2018-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
03662674000259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662674000259036626740002593662674000259

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

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