injeTAK Adjustable Tip Needle 35cm

GUDID 20627825000011

Laborie Medical Technologies Canada ULC

General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use

• Primary Device ID: 20627825000011
• NIH Device Record Key: 07b99dbb-abfb-4893-bf24-b8ffa075ccb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: injeTAK Adjustable Tip Needle 35cm
• Version Model Number: DIS199
• Company DUNS: 203383526
• Company Name: Laborie Medical Technologies Canada ULC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627825000017 [Primary]
GS1	10627825000014 [Package]; Contains: 00627825000017; Package: [2 Units]; In Commercial Distribution
GS1	20627825000011 [Package]; Contains: 10627825000014; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090830

FDA Product Code

• FBK: endoscopic injection needle, gastroenterology-urology

Sterilization

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

[20627825000011]

Ethylene Oxide

[20627825000011]

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: 2016-09-21

Devices Manufactured by Laborie Medical Technologies Canada ULC

• 30627825007024 - Extension Set 2: 2022-07-04
• 20627825007294 - Extension Line, 60 cm: 2022-07-04
• 20627825007317 - Extension Line, 1500mm: 2022-07-04
• 20627825007324 - Extension Line, 15cm: 2022-07-04
• 20627825007348 - Extension Line, 150cm Blue: 2022-07-04
• 30627825007352 - Extension Line, 150cm Yellow: 2022-07-04
• 20627825007034 - Extension Set 3: 2022-07-04
• 30627825007307 - Extension Line, 90 cm: 2022-07-04