Epimed International, Inc. 197-3522

GUDID 10818788021509

Plastic L.O.R./ 22g x 3.5" Tuohy

EPIMED INTERNATIONAL, INC

Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded

• Primary Device ID: 10818788021509
• NIH Device Record Key: 34e1ed35-5571-4dd9-8d57-e62c5f9e898d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epimed International, Inc.
• Version Model Number: 197-3522
• Catalog Number: 197-3522
• 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: true
• 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

Device Dimensions

• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge
• Length: 3.5 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 22 Gauge

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
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• 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	00818788021502 [Primary]
GS1	10818788021509 [Package]; Contains: 00818788021502; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030562

FDA Product Code

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

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

[10818788021509]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-13
• Device Publish Date: 2022-05-05

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• 10818788021509: Plastic L.O.R./ 22g x 3.5" Tuohy
• 10818788021486: Plastic L.O.R./ 20g x 3.5" Tuohy