i-Thread

GUDID 08800056425176

i-Thread (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.

Hyundae Meditech Co., Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 08800056425176
• NIH Device Record Key: 3d8462a5-a313-4229-a003-9e3f01003564
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Thread
• Version Model Number: FCRL18100C185
• 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: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 Millimeter
• Length: 185 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	08800056425176 [Primary]
GS1	48800056425174 [Package]; Package: Pouch [10 Units]; In Commercial Distribution
GS1	88800056425172 [Package]; Contains: 48800056425174; 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

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

[08800056425176]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• 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