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Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name
Surgical Direct FDA UDI
Generic Name
Orthopaedic bone-fragment manipulator, reusable FDA UDI
Device Name
4 3/4" Lowman Bone Holding Clamp, 1 x 2 FDA UDI
Model / Reference
SD91415516 FDA UDI
Description
4 3/4" Lowman Bone Holding Clamp, 1 x 2 FDA UDI

Identifiers

Catalog Number
SD91415516 FDA UDI
Primary DI / UDI-DI
B382SD914155160 FDA UDI
FDA Product Code
GEN FDA UDI
GMDN Term
Orthopaedic bone-fragment manipulator, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone-fragment manipulator, reusable

Surgical Direct by Surgical Direct, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone-fragment manipulator, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgical Direct, Inc.

Sources (1)

  • FDA UDI cd6f8487-b02e-46cc-b8b6-442fd913930a 35 fields · synced May 30, 2026