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Flow-Nail™

FDA UDI

Class I (US FDA UDI)

by Flow-Fx, LLC

Identity

Trade Name
Flow-Nail™ FDA UDI
Generic Name
Surgical torque wrench, reusable FDA UDI
Device Name
FN Breaker Bar Wrench FDA UDI
Model / Reference
101-02 FDA UDI
Description
FN Breaker Bar Wrench FDA UDI

Identifiers

Catalog Number
101-02 FDA UDI
Primary DI / UDI-DI
B267101020 FDA UDI
510(k) Number
K140601 FDA UDI
FDA Product Code
HXC FDA UDI
GMDN Term
Surgical torque wrench, 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical torque wrench, reusable

Flow-Nail™ by Flow-Fx, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical torque wrench, reusable.

Cleared under the same submission

K140601 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flow-Fx, LLC

Sources (1)

  • FDA UDI db498947-0545-4aaf-a3eb-7271b1e6f5dc 35 fields · synced May 31, 2026