Disposable Impactor - No Guidewire

Basic Information

• Brand Name: Disposable Impactor - No Guidewire
• Primary DI: 00850040139815
• Version / Model: SR19-3200
• Company Name: SURGENTEC, LLC
• Labeler DUNS: 004095409
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-23
• Public Version: 4
• Public Version Date: 2026-04-20
• Public Version Status: Update
• Public Device Record Key: f7a05e51-879c-4750-8bc3-b77cf1f16c39
• Distribution End Date: 2026-04-16

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MRW	System, Facet Screw Spinal Device	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58109	Implantable cervical facet joint distractor	A non-powered wedge-shaped device intended to be inserted within a cervical facet joint (spinal joint), i.e., intra-facet, for joint distraction; the distraction is intended to facilitate nerve root decompression and stabilization of the spine in the treatment of various spinal conditions. It is typically fenestrated or barbed and may incorporate a screw to expand to shape and/or to provide fixation within the joint and cervical spine stabilization. It typically includes single-use instruments (e.g., chisels, rasps) for implantation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850040139815	GS1

Premarket Submissions

Submission Number	Supplement Number
K240086	000