SPRINT™ 9239

GUDID 00854001007250

SPRINT™ MicroLead (20cm) and Accessories

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: 00854001007250
• NIH Device Record Key: dc837a15-5efb-40c6-852c-69efde094aa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPRINT™
• Version Model Number: MicroLead (20cm) and Accessories
• Catalog Number: 9239
• Company DUNS: 963383778
• Company Name: SPR THERAPEUTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00854001007250 [Primary]

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-01-19

On-Brand Devices [SPRINT™]

• 00854001007373: Single Procedure Kit w/ Pad II
• 00854001007366: Single Procedure Kit w/ Pad I
• 00854001007359: SPRINT™ Single Procedure Kit with Pad II
• 00854001007342: SPRINT™ Pad II Kit (15 Pads)
• 00854001007335: SPRINT™ PNS Stimulator Kit
• 00854001007328: SPRINT™ PNS Multi-Procedure Kit
• 00854001007311: SPRINT™ PNS Single Procedure Kit
• 00854001007304: SPRINT™ Fifteen (15) Pads Kit
• 00854001007298: SPRINT™ Sterile Components Kit
• 00854001007281: SPRINT™ Stimulator, Pad II, and Accessories
• 00854001007274: Fifteen (15) SPRINT™ Pad II
• 00854001007267: SPRINT™ PNS Stimulator, Storage Bag, Patient Cables, and IFU
• 00854001007250: SPRINT™ MicroLead (20cm) and Accessories
• 00854001007243: SPRINT™ Stimulator, Pads, and Accessories
• 00854001007236: Fifteen (15) SPRINT™ Pads
• 00854001007229: SPRINT™ Long Cable
• 00854001007205: SPRINT™ Short Cable
• 00854001007182: SPRINT™ PNS Stimulator
• 00854001007168: SPRINT™ Test Needle
• 00854001007137: SPRINT™ Test Needle
• 00854001007113: SPRINT™ MicroLead (20cm) and Introducer
• 00854001007076: SPRINT™ Test Cable
• 00854001007052: SPRINT™ Lead Connector and Wrench
• 00854001007014: Five (5) SPRINT™ Pads