SPRINT 9288-6002

GUDID 00854001007557

SPRINT Extensa, Sales Configuration

SPR THERAPEUTICS, INC.

Analgesic percutaneous electrical nerve stimulation system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system

• Primary Device ID: 00854001007557
• NIH Device Record Key: a53d8e36-031f-42d1-ada9-d19ce7fd113c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPRINT
• Version Model Number: Extensa, Sales Configuration
• Catalog Number: 9288-6002
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854001007557 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-09-14

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