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Quantum

FDA UDI

Class I (US FDA UDI)

by In2bones

Identity

Trade Name
QUANTUM FDA UDI
Generic Name
Orthopaedic bur, reusable FDA UDI
Device Name
QUANTUM Drill Ø2.5 mm For Stamping FDA UDI
Model / Reference
M05 00711 FDA UDI
Description
QUANTUM Drill Ø2.5 mm For Stamping FDA UDI

Identifiers

Catalog Number
M05 00711 FDA UDI
Primary DI / UDI-DI
03701337600709 FDA UDI
510(k) Number
K191380 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
Orthopaedic bur, 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 120 Millimeter FDA UDI

Category: Orthopaedic bur, reusable

Quantum by In2bones — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bur, reusable.

Cleared under the same submission

K191380 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
In2bones

Sources (1)

  • FDA UDI 52889544-2392-4b09-9737-44803febe82f 37 fields · synced Jun 8, 2026