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Lightning

FDA UDI

Class I (US FDA UDI)

by Responsive Orthopedics Llc

Identity

Trade Name
Lightning FDA UDI
Generic Name
Fluted surgical drill bit, reusable FDA UDI
Device Name
Lightning Standard Drill Medium FDA UDI
Model / Reference
905001-0002-P02 FDA UDI
Description
Lightning Standard Drill Medium FDA UDI

Identifiers

Catalog Number
905001-0002-P02 FDA UDI
Primary DI / UDI-DI
00811714035406 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Fluted surgical drill bit, 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Fluted surgical drill bit, reusable

Lightning by Responsive Orthopedics Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluted surgical drill bit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Responsive Orthopedics Llc

Sources (1)

  • FDA UDI b9ac774e-05b0-4edd-8567-279e8eb6591f 34 fields · synced Jun 6, 2026