PEDIGUARD THREADED D1SP0001

GUDID 03662674000372

SPINEGUARD

Bone awl, reusable

• Primary Device ID: 03662674000372
• NIH Device Record Key: bef40c32-fbf3-47e0-a9ee-8b4b0e85139c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEDIGUARD THREADED
• Version Model Number: STARTER Pin 1
• Catalog Number: D1SP0001
• Company DUNS: 260589566
• Company Name: SPINEGUARD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33145184519
• Email: qara@spineguard.com
• Phone: +33145184519
• Email: qara@spineguard.com
• Phone: +33145184519
• Email: qara@spineguard.com
• Phone: +33145184519
• Email: qara@spineguard.com
• Phone: +33145184519
• Email: qara@spineguard.com
• Phone: +33145184519
• Email: qara@spineguard.com

Device Dimensions

• Length: 308 Millimeter
• Outer Diameter: 1.6 Millimeter
• Length: 308 Millimeter
• Outer Diameter: 1.6 Millimeter
• Length: 308 Millimeter
• Outer Diameter: 1.6 Millimeter
• Length: 308 Millimeter
• Outer Diameter: 1.6 Millimeter
• Length: 308 Millimeter
• Outer Diameter: 1.6 Millimeter
• Length: 308 Millimeter
• Outer Diameter: 1.6 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662674000372 [Primary]

FDA Product Code

• GAH: Stylet, Surgical, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-12-26

On-Brand Devices [PEDIGUARD THREADED]

• 03662674000266: DSG Technology Instrument Set - Lid
• 03662674000259: DSG Technology Instrument Set - Base
• 03662674000464: DSG Threaded Shaft A LK - Ø4.5mm
• 03662674000457: DSG Threaded Shaft A LK - Ø5.5mm
• 03662674000365: DSG Threaded Shaft F - Ø4.0mm
• 03662674000358: DSG Threaded Shaft K - Ø5.5mm
• 03662674000341: DSG Threaded Shaft K - Ø4.5mm
• 03662674000334: DSG Threaded Shaft B - Ø6.5mm
• 03662674000327: DSG Threaded Shaft B - Ø4.5mm
• 03662674000303: DSG Threaded Shaft J - Ø4.5mm
• 03662674000297: DSG Threaded Shaft H - Ø5.5mm
• 03662674000280: DSG Threaded Shaft G - Ø5.0mm
• 03662674000273: DSG Threaded Shaft A - Ø4.5mm
• 03662674000235: DSG Ratcheting Handle A
• 03662674000228: DSG Threaded Shaft C - Ø5.5mm
• 03662674000211: DSG Threaded Shaft B - Ø5.5mm
• 03662674000204: DSG Threaded Shaft A - Ø5.5mm
• 03662674000389: STARTER Pin 5
• 03662674000372: STARTER Pin 1
• 03662674000198: DSG Pin 5
• 03662674000174: DSG Pin 1