Epimed International, Inc.

GUDID 10818788022995

AX-S Epidural Needle 14g TW x 4.0"

EPIMED INTERNATIONAL, INC

Epidural needle, non-threaded

• Primary Device ID: 10818788022995
• NIH Device Record Key: aef8fa33-c1b6-4c57-87d7-8346ad5ce6a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epimed International, Inc.
• Version Model Number: 104-1314
• Company DUNS: 799751953
• Company Name: EPIMED INTERNATIONAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818788022998 [Primary]
GS1	10818788022995 [Package]; Contains: 00818788022998; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053318

FDA Product Code

• BSP: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

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: 2026-03-25
• Device Publish Date: 2026-03-17

On-Brand Devices [Epimed International, Inc.]

• 10818788020410: RF™ Coudé® Blunt 20g TW x 10cm with 15mm Active Tip
• 10818788021431: RF™ Coudé® B Bevel 20g x 5cm with 10mm Active Tip
• 10818788020540: Plastic L.O.R./ 18g x 3.5" Tuohy
• 10818788023695: Percutaneous Introducer w/ 14g RW x 2.75" B Bevel needle with sidearm injection port and hemosta
• 10818788021509: Plastic L.O.R./ 22g x 3.5" Tuohy
• 10818788021486: Plastic L.O.R./ 20g x 3.5" Tuohy
• 00818788022295: PainBlocker Console (CO²), Foot and Cart
• 10818788022995: AX-S Epidural Needle 14g TW x 4.0"