PediGuard DSG Connect P1-AU550

GUDID 03662674000501

SPINEGUARD

Bone awl, single-use
Primary Device ID03662674000501
NIH Device Record Keybd00c92c-2531-4e6e-94c2-f38fe5b78516
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediGuard DSG Connect
Version Model NumberPediGuard DSG Connect Curv
Catalog NumberP1-AU550
Company DUNS260589566
Company NameSPINEGUARD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103662674000501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PDQNeurosurgical Nerve Locator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-25
Device Publish Date2025-09-17

On-Brand Devices [PediGuard DSG Connect]

03662674000488PediGuard DSG Connect Ø3.2
03662674000471PediGuard DSG Connect Ø4.0
03662674000525PediGuard DSG Connect Curv XS
03662674000518PediGuard DSG Connect Ø2.5 XS
03662674000501PediGuard DSG Connect Curv
03662674000495PediGuard DSG Connect Ø2.5

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