Epimed 106-1312

GUDID 10818788020212

RX Epidural Needle 12g TW x 5.0"

EPIMED INTERNATIONAL, INC

Epidural needle, non-threaded

• Primary Device ID: 10818788020212
• NIH Device Record Key: b989dbc4-d243-4253-9d23-6a40b30c9602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epimed
• Version Model Number: 106-1312
• Catalog Number: 106-1312
• Company DUNS: 799751953
• Company Name: EPIMED INTERNATIONAL, INC
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)866-3342
• Email: customerservice@epimed.com
• Phone: +1(800)866-3342
• Email: customerservice@epimed.com

Device Dimensions

• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818788020215 [Primary]
GS1	10818788020212 [Package]; Contains: 00818788020215; Package: Case [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: true
• Device Is Sterile: true

[10818788020212]

Ethylene Oxide

[10818788020212]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-20

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