Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Scalpel handle, reusable FDA UDI
- Device Name
- A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device. FDA UDI
- Model / Reference
- SHS FDA UDI
- Description
- A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075626271 FDA UDI
- FDA Product Code
- EJB FDA UDI
- GMDN Term
- Scalpel handle, 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
Moist Heat or Steam Sterilization FDA UDI
Category: Scalpel handle, 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 Scalpel handle, reusable.
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- KNIFE HANDLE — SONTEC INSTRUMENTS, INC. · Class I
- SCALPEL HANDLE #4 — W.H. Holden, Inc. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Anterior Disc Prep — SeaSpine Orthopedics Corporation · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · 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
- Osung Mnd Co., Ltd.
Sources (1)
- FDA UDI 1ad49a14-3fe9-4acf-96bc-8b8cdd53f4e7 33 fields · synced May 30, 2026