ReShape Medical™ Guidewire RSM300

GUDID 00850758007109

ReShape Medical™ Guidewire .035” x 260 cm, 13 cm (Straight Tip)

TECHDEVICE CORPORATION

General-purpose non-vascular guidewire

• Primary Device ID: 00850758007109
• NIH Device Record Key: 98717a7d-165f-46e0-bd34-31081d3a0d05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReShape Medical™ Guidewire
• Version Model Number: RSM300
• Catalog Number: RSM300
• 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: 260 Centimeter
• Length: 260 Centimeter
• Length: 260 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850758007109 [Primary]

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: 3
• Public Version Date: 2018-06-12
• Device Publish Date: 2016-09-23

Devices Manufactured by TECHDEVICE CORPORATION

• 00850758007000 - Mermaid Medical® Guidewire: 2018-07-06 Mermaid Medical® Guidewire .035” x 90 cm, 7.5 cm (Straight Tip)
• 00850758007017 - Mermaid Medical® Guidewire: 2018-07-06 Mermaid Medical® Guidewire .035” x 90 cm, 3.5 cm (Straight Tip)
• 00850758007024 - Mermaid Medical® Guidewire: 2018-07-06 Mermaid Medical® Guidewire .035” x 90 cm, 7.5 cm Tip (3mm “J”)
• 00850758007031 - Mermaid Medical® Guidewire: 2018-07-06 Mermaid Medical® Guidewire .035” x 150 cm, 7.5 cm (Straight Tip)
• 00850758007048 - Mermaid Medical® Guidewire: 2018-07-06 Mermaid Medical® Guidewire .035” x 150 cm, 3.5 cm (Straight Tip)
• 00850758007055 - Mermaid Medical® Guidewire: 2018-07-06 Mermaid Medical® Guidewire .035” x 180 cm, 7.5 cm (Straight Tip)
• 00850758007062 - Mermaid Medical® Guidewire: 2018-07-06 Mermaid Medical® Guidewire .035” x 180 cm, 3.5 cm (Straight Tip)
• 00850758007079 - Mermaid Medical® Guidewire: 2018-07-06 Mermaid Medical® Guidewire .035” x 260 cm, 7.5 cm (Straight Tip)