Teca Elite

GUDID 00382830017480

TECA ELITE Disposable Concentric Red Needle, 25mm, .3(30G) diameter, 25 per Pk

NATUS MANUFACTURING LIMITED

Electromyographic needle electrode, single-use

• Primary Device ID: 00382830017480
• NIH Device Record Key: 773a637f-ab83-4afa-adec-9a213979f0d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teca Elite
• Version Model Number: S53153
• Company DUNS: 896421240
• Company Name: NATUS MANUFACTURING LIMITED
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830017480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112034

FDA Product Code

• IKT: Electrode, Needle, Diagnostic Electromyograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-25

On-Brand Devices [Teca Elite ]

• 00382830017589: TECA Elite Disposable Monopolar Violet Needle, 75mmx26G (24) per PK
• 00382830017572: TECA Elite Disposable Monopolar Blue Needle, 50mmx26G (48) per PK
• 00382830017565: TECA Elite Disposable Monopolar Green Needle, 37mmx26G (48) per PK
• 00382830017558: TECA Elite Disposable Monopolar Yellow Needle, 25mmx26G (48) per PK
• 00382830017541: TECA Elite Disposable Monopolar Orange Needle, 37mmx28G (48) per PK
• 00382830017534: TECA Elite Disposable Monopolar Red Needle, 25mmx28G (48) per PK
• 00382830017527: TECA ELITE Disposable Concentric Violet Needle, 75mm, .64(23G) diameter, 25 per Pk
• 00382830017510: TECA ELITE Disposable Concentric Blue Needle, 50mm, .46(26G) diameter, 25 per Pk
• 00382830017503: TECA ELITE Disposable Concentric Green Needle, 37mm,.46(26G) diameter, 25 per Pk
• 00382830017497: TECA ELITE Disposable Concentric Yellow Needle, 25mm, .46(26G) diameter, 25 per Pk
• 00382830017480: TECA ELITE Disposable Concentric Red Needle, 25mm, .3(30G) diameter, 25 per Pk