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Flow-Screw™

FDA UDI

Class I (US FDA UDI)

by Flow-Fx, LLC

Identity

Trade Name
Flow-Screw™ FDA UDI
Generic Name
Cannulated surgical drill bit, single-use, non-sterile FDA UDI
Device Name
6.5/7.3 F-S Short Drill/FS CAN Drill 4.8 mm Short FDA UDI
Model / Reference
102-01-03S FDA UDI
Description
6.5/7.3 F-S Short Drill/FS CAN Drill 4.8 mm Short FDA UDI

Identifiers

Catalog Number
102-01-03S FDA UDI
Primary DI / UDI-DI
B2671020103S0 FDA UDI
510(k) Number
K142776 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
Cannulated surgical drill bit, single-use, non-sterile 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: Cannulated surgical drill bit, single-use, non-sterile

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

Similar devices

Also classified as Cannulated surgical drill bit, single-use, non-sterile.

Cleared under the same submission

K142776 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 0acc2b54-8c77-4ba1-b1a0-b3f68a57cca6 35 fields · synced Jun 1, 2026