AcuJect Flex AJ FLEX 25 230 10

GUDID 10816207021215

Endoscopic injection needle

ENDO-THERAPEUTICS, INC.

General-purpose endoscopic needle, single-use

• Primary Device ID: 10816207021215
• NIH Device Record Key: 402b5dfc-1cdc-4a44-9353-ca16a52e8ea4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcuJect Flex
• Version Model Number: AJ FLEX 25 230 10
• Catalog Number: AJ FLEX 25 230 10
• Company DUNS: 825239189
• Company Name: ENDO-THERAPEUTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com

Device Dimensions

• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816207021218 [Primary]
GS1	10816207021215 [Package]; Contains: 00816207021218; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012977

FDA Product Code

• FBK: Endoscopic Injection Needle, Gastroenterology-Urology

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: 2019-12-11
• Device Publish Date: 2019-12-03

On-Brand Devices [AcuJect Flex]

• 10816207021215: Endoscopic injection needle
• 10816207021253: Endoscopic injection needle