SPRINT 9288-6003

GUDID 00850022775215

SPRINT extensa XT PNS System, Sales Configuration

SPR THERAPEUTICS, INC.

Analgesic PENS system

• Primary Device ID: 00850022775215
• NIH Device Record Key: 2059e66d-a255-4007-9935-80355b84d626
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPRINT
• Version Model Number: 9288-6003
• Catalog Number: 9288-6003
• Company DUNS: 963383778
• Company Name: SPR THERAPEUTICS, INC.
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850022775215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223306

FDA Product Code

• NHI: Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-21
• Device Publish Date: 2023-04-13

On-Brand Devices [SPRINT]

• 00854001007625: Mounting Cradles, Pack of Five
• 00854001007618: Clinical Programmer, Shipping Configuration
• 00854001007601: Clinical Programmer, Sales Configuration
• 00854001007595: SPRINT Extensa, Shipping Configuration
• 00854001007588: SPRINT Endura, Shipping Configuration
• 00854001007571: Patient Kit, SPRINT Extensa
• 00854001007564: Patient Kit, SPRINT Endura
• 00854001007557: SPRINT Extensa, Sales Configuration
• 00854001007540: SPRINT Endura, Sales Configuration
• 00854001007533: Sales Box, Dual-Lead Cable Tray, Sterile
• 00854001007526: Sales Box, Single-Lead Cable Tray, Sterile
• 00854001007502: Sales Box, EPG Tray, Extensa
• 00854001007496: Sales Box, EPG Tray, Endura
• 00854001007489: Sales Box, Lead Tray, Sterile
• 00854001007472: Dual-Lead Cable Tray, Sterile
• 00854001007465: Single-Lead Cable Tray, Sterile
• 00854001007441: EPG Tray, Extensa
• 00854001007434: EPG Tray, Endura
• 00854001007427: Lead Tray, Sterile
• 00854001007410: SPRINT Mounting Pad, Non-Sterile
• 00854001007403: SPRINT Mounting Pad, Sterile
• 00854001007960: SPRINT MicroLead with OnePass Introducer; Sales Box, Lead Tray Without Test Needle, Sterile
• 00854001007953: SPRINT Microlead with OnePass Introducer; Lead Tray Without Test Needles, Sterile
• 00854001007922: Mounting Pad, Non-Sterile
• 00854001007915: Replacement MicroLead Connector Key, Sterile
• 00854001007908: Replacement Dual Lead Adapter, Sterile
• 00854001007892: Replacement MicroLead Connector and Key, Dark Gray, Sterile
• 00854001007885: Replacement MicroLead Connector and Key, Light Gray, Sterile
• 00854001007878: Replacement Magnetic Coupler, Dark Gray, Sterile
• 00854001007861: Replacement Magnetic Coupler, Light Gray, Sterile
• 00854001007854: Replacement Long Patient Extension Cable, Dark Gray, Sterile
• 00854001007847: Replacement Long Patient Extension Cable, Light Gray, Sterile
• 00854001007830: Replacement Short Patient Extension Cable, Dark Gray, Sterile
• 00854001007823: Replacement Short Patient Extension Cable, Light Gray, Sterile
• 00854001007816: Replacement Dual Lead Adapter, Non-Sterile
• 00854001007809: Replacement MicroLead Connector and Key, Dark Channel, Non-Sterile
• 00854001007793: Replacement MicroLead Connector and Key, Light Gray, Non-Sterile
• 00854001007786: Replacement Magnetic Coupler, Dark Gray, Non-Sterile
• 00854001007779: Replacement Magnetic Coupler, Light Gray, Non-Sterile
• 00854001007762: Replacement Long Patient Extension Cable, Dark Gray, Non-Sterile
• 00854001007755: Replacement Long Patient Extension Cable, Light Gray, Non-Sterile
• 00854001007748: Replacement Short Patient Extension Cable, Dark Gray, Non-Sterile
• 00854001007731: Replacement Short Patient Extension Cable, Light Gray, Non-Sterile
• 00854001007724: Mounting Pad, Non-Sterile
• 00854001007717: Replacement Handheld Remote
• 00854001007663: Rechargeable Battery Replacement
• 00854001007656: Replacement Recharging Base, Power Supply, & USB Cable
• 00854001007649: Microlead with OnePass Introducer Replacement
• 00854001007632: Microlead with OnePass Introducer Replacement
• 00854001007984: Magnetic Stimulating Probe and Universal Test Cable, Sterile, Sales Box