FDA.reportPublic FDA data

PEDIGUARD THREADED

Primary DI
03662674000389
Brand
PEDIGUARD THREADED
Company
SPINEGUARD
Model
STARTER Pin 5
Catalog number
D1SP0005
Published
2016-12-26
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
GAHStylet, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAHStylet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662674000389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662674000389036626740003893662674000389

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

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
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
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03662663192897Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192903Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192910Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192927Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
00873263009314Visualase Neuro AccessoriesFHC, INC.GAH2025-12-12
00873263009338Visualase MR Stiffening StyletFHC, INC.GAH2025-12-12
03662663131414Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131506Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131513Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131520Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131537Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
08809204330522LIONHans Biomed Corp.GAH2025-11-26
08809204330539LIONHans Biomed Corp.GAH2025-11-26
08809204330546LIONHans Biomed Corp.GAH2025-11-26
08809204330553LIONHans Biomed Corp.GAH2025-11-26
08809204330560LIONHans Biomed Corp.GAH2025-11-26
08809204330577LIONHans Biomed Corp.GAH2025-11-26
08809204330584LIONHans Biomed Corp.GAH2025-11-26
08809204330591LIONHans Biomed Corp.GAH2025-11-26
08809204330607LIONHans Biomed Corp.GAH2025-11-26
08809204330614LIONHans Biomed Corp.GAH2025-11-26
08809204330621LIONHans Biomed Corp.GAH2025-11-26
08809204330638LIONHans Biomed Corp.GAH2025-11-26
08809204330645LIONHans Biomed Corp.GAH2025-11-26
08809204330652LIONHans Biomed Corp.GAH2025-11-26
08809779585853LIONHans Biomed Corp.GAH2025-11-26
08809779585877LIONHans Biomed Corp.GAH2025-11-26
08809204330515LIONHans Biomed Corp.GAH2025-11-18
00873263009062Visualase Neuro AccessoriesFHC, INC.GAH2025-03-10