AGUPUNT IPEN

Basic Information

• Brand Name: AGUPUNT IPEN
• Primary DI: 08437016482339
• Version / Model: A1009BE
• Company Name: AGU PUNT SL
• Labeler DUNS: 476185710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2022-04-27
• Public Version: 1
• Public Version Date: 2022-05-05
• Public Version Status: New
• Public Device Record Key: c923d802-ca92-4347-8db1-a5f5cda12c12

Device Description

Physiotherapy needles

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
MQX	Needle, Acupuncture, Single Use	General Hospital	880.5580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62176	Dry-needling needle	A sterile, thin, non-hollow, sharply-pointed metallic instrument intended for use during a dry-needling procedure to treat various musculoskeletal, nervous and/or pain symptoms. It is typically used as part of a physiotherapy treatment regime, and involves introducing the needle percutaneously into the myofascial layer with some manipulation; no medication or extrinsic energy is involved. It is typically supplied in a protective sheath. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	18437016482336	GS1
Primary	08437016482339	GS1

Premarket Submissions

Submission Number	Supplement Number
K003748	000