i-Thread

GUDID 08800056424223

Determined based on the confidentiality designation assigned to the proprietary brand name associated to the listing number in the Device Registration and Listing Module(DRLM) database. In order to make changes to the Public Release status, please review your confidentiality designation in DRLM.

Hyundae Meditech Co., Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 08800056424223
• NIH Device Record Key: f966ac31-8689-4fa5-886f-67c151d2113a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Thread
• Version Model Number: FCL19100E160
• Company DUNS: 688991019
• Company Name: Hyundae Meditech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter
• Length: 160 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800056424223 [Primary]
GS1	48800056464227 [Package]; Package: Pouch [10 Units]; In Commercial Distribution
GS1	88800056424229 [Package]; Contains: 48800056464227; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242571

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

Sterilization

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

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

[08800056424223]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-23
• Device Publish Date: 2025-07-15

On-Brand Devices [i-Thread]

• 48800056425297: i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is
• 48800056424221: i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is
• 08800056425329: i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is
• 08800056425305: i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is
• 08800056425299: i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is
• 08800056425183: i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is
• 08800056425176: i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is
• 08800056424223: Determined based on the confidentiality designation assigned to the proprietary brand name assoc