ALARA 11 Gauge Access Needle with Sheath - Diamond Tip

Basic Information

• Brand Name: ALARA 11 Gauge Access Needle with Sheath - Diamond Tip
• Primary DI: 00810131881382
• Version / Model: AAN-09-S
• Company Name: SURGENTEC, LLC
• Labeler DUNS: 004095409
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-29
• Public Version: 2
• Public Version Date: 2025-11-07
• Public Version Status: Update
• Public Device Record Key: dd45ea31-e9cc-4ebf-b61c-8f60ea32d6df

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: Yes
• 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
GDF	Guide, Needle, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66417	Spinal introduction needle	A sharp, beveled-edge, hollow tubular instrument with a hub at the proximal end, designed to make the initial percutaneous puncture to enable subsequent introduction of a spinal needle. It is typically made of metal and polymer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810131881382	GS1