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Osung Mnd

FDA UDI

Class I (US FDA UDI)

by Osung Mnd Co., Ltd.

Identity

Trade Name
OSUNG MND FDA UDI
Generic Name
Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
Device Name
A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use. FDA UDI
Model / Reference
HTK145 FDA UDI
Description
A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use. FDA UDI

Identifiers

Primary DI / UDI-DI
08800075610089 FDA UDI
FDA Product Code
EMD FDA UDI
GMDN Term
Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical soft-tissue manipulation forceps, scissors-like, reusable

Osung Mnd by Osung Mnd Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical soft-tissue manipulation forceps, scissors-like, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osung Mnd Co., Ltd.

Sources (1)

  • FDA UDI 11129123-2bb3-4aa9-b1f4-4c293e3fb08b 33 fields · synced May 31, 2026