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i-Thread

FDA UDI

Class II (US FDA UDI)

by Hyundae Meditech Co., Ltd.

Identity

Trade Name
i-Thread FDA UDI
Generic Name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Device Name
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. FDA UDI
Model / Reference
FCL18100C160 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
48800056425297 FDA UDI
510(k) Number
K242571 FDA UDI
FDA Product Code
NEW FDA UDI
GMDN Term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4840 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 160 Millimeter FDA UDI

i-Thread by Hyundae Meditech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K242571 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hyundae Meditech Co., Ltd.

Sources (1)

  • FDA UDI f2f24247-0e1a-4078-a767-11c17303574a 37 fields · synced Jun 8, 2026