Kmedic

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: KMEDIC FDA UDI
Generic Name: Suturing unit, reusable FDA UDI
Device Name: SUTURE PASSER 9 1/4" CURVED WITH HOLE FDA UDI
Model / Reference: IPN014057 FDA UDI
Description: SUTURE PASSER 9 1/4" CURVED WITH HOLE FDA UDI

Identifiers

Catalog Number: KM46918 FDA UDI
Primary DI / UDI-DI: 24026704273281 FDA UDI
FDA Product Code: HWQ FDA UDI
GMDN Term: Suturing unit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 23.5 Centimeter FDA UDI

Category: Suturing unit, reusable

Kmedic by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suturing unit, reusable.

Hip Suture Grasper — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
Arthrex® — Arthrex, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
Suture Manipulator Grasper — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
Knot Manipulator Full Loop — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
Arthrex® — Arthrex, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
HAT-TRICK — Smith & Nephew, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI 97342353-026a-4550-be1b-e65bb1c83672 36 fields · synced Jun 7, 2026