Minuteman

GUDID M943350002000

Single-Use Guide Wire Accessory Kit

Spinal Simplicity, LLC

Wire/ligature passer, single-use

• Primary Device ID: M943350002000
• NIH Device Record Key: 623c3878-b252-4cb8-a3d3-d68a933c915d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Minuteman
• Version Model Number: 35-0002-000
• Company DUNS: 963359513
• Company Name: Spinal Simplicity, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M943350002000 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-17
• Device Publish Date: 2023-08-09

On-Brand Devices [Minuteman]

• M9432000990001: Starter Rasp
• M9432000140001: Dilator/Sleeve Handle
• M9432000130001: Direct Drive T-Handle
• M9432000120001: Wing Reset Instrument
• M9432000940081: Speed Adapter Hex, Open Sz. 8mm
• M9432000210001: Plunger
• M9432000200001: OP Graduated Tap
• M9432000490001: Aiming Device Support Handle
• M9432000280001: Wrench SZ 12/14
• M9432000270001: Wrench SZ 8/10
• M9432000260001: Minuteman Insertion Instrument
• M9432000240001: Modular Handle
• M9432000920141: Insertion Adaptor, Extended, Sz. 14mm
• M9432000920121: Insertion Adaptor, Extended, Sz. 12mm
• M9432000920101: Insertion Adaptor, Extended, Sz. 10mm
• M9432000920081: Insertion Adaptor, Extended, Sz. 8mm
• M9432000590001: Forceps
• M9432000580001: Awl
• M9432000570001: Distractor
• M9432000940141: Speed Adapter Hex, Open Sz. 14mm
• M9432000940121: Speed Adapter Hex, Open Sz. 12mm
• M9432000940101: Speed Adapter Hex, Open Sz. 10mm
• M9432000970001: Hex L-Key
• M9432000960121: Hex Adapter Housing Assembly
• M9432000960101: Hex Adapter Housing Assembly
• M9432000960081: Hex Adapter Housing Assembly
• M9432001240001: Mini Pathfinder
• M9432001210001: Ratchet Wrench with lock sleeve, Manual
• M9432001040001: Mini Wing Reset
• M9432001010001: Adapter, Hex, Manual Ratchet Driver Assembly
• M9432001470001: Insertion Adaptor, Extended, Sz. 14/16 MM
• M9432001460001: Insertion Adaptor, Extended, Sz. 8/10/12 MM
• M9432000940161: Speed Adapter Hex, Open Sz. 16mm
• M9432000920161: Insertion Adaptor, Extended, Sz. 16mm
• M9432000020001: Guide Wire Extension
• M9432001190001: Minuteman G3-R Wing Reset Instrument
• M9432000290011: Speed Wrench SZ 16
• M9432000280011: Speed Wrench SZ 12/14
• M9432000270011: Speed Wrench SZ 8/10
• M9432001380001: Weitlaner Retractor 16.5cm
• M9432001370001: Bone Tamp 7mm
• M9432001360001: Leksell Bone Rongeur Lightly Curved 7 mm
• M9432001350001: Ruskin Rongeur 5mm Jaws 18.4cm
• M9432001340001: Heath Mallet 19cm
• M9432001330001: Cobb Spinal Elevator 28cm
• M9432001320001: Wiltse-Gelpi Retractor 28cm
• M943350002000: Single-Use Guide Wire Accessory Kit
• M943350001000: MIS Lateral Single-Use Instrument Kit
• M9432000960161: Hex Adapter Housing Assembly
• M9432001580000: Surgical Probe