Mermaid Medical® Guidewire G60135090

GUDID 00850758007000

Mermaid Medical® Guidewire .035” x 90 cm, 7.5 cm (Straight Tip)

TECHDEVICE CORPORATION

Peripheral vascular guidewire, manual

• Primary Device ID: 00850758007000
• NIH Device Record Key: b311b790-909c-47d2-b39a-cce7191b2fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mermaid Medical® Guidewire
• Version Model Number: G60135090
• Catalog Number: G60135090
• Company DUNS: 088189175
• Company Name: TECHDEVICE CORPORATION
• 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

Device Dimensions

• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 90 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850758007000 [Primary]
GS1	20850758007004 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053251

FDA Product Code

• DQX: Wire, Guide, Catheter

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: 2016-09-23

On-Brand Devices [Mermaid Medical® Guidewire]

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• 00850758007079: Mermaid Medical® Guidewire .035” x 260 cm, 7.5 cm (Straight Tip)
• 00850758007062: Mermaid Medical® Guidewire .035” x 180 cm, 3.5 cm (Straight Tip)
• 00850758007055: Mermaid Medical® Guidewire .035” x 180 cm, 7.5 cm (Straight Tip)
• 00850758007048: Mermaid Medical® Guidewire .035” x 150 cm, 3.5 cm (Straight Tip)
• 00850758007031: Mermaid Medical® Guidewire .035” x 150 cm, 7.5 cm (Straight Tip)
• 00850758007024: Mermaid Medical® Guidewire .035” x 90 cm, 7.5 cm Tip (3mm “J”)
• 00850758007017: Mermaid Medical® Guidewire .035” x 90 cm, 3.5 cm (Straight Tip)
• 00850758007000: Mermaid Medical® Guidewire .035” x 90 cm, 7.5 cm (Straight Tip)