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Darby Dental Supply, LLC

FDA UDI

Class I (US FDA UDI)

by Darby Dental Supply, Llc

Identity

Trade Name
Darby Dental Supply, LLC FDA UDI
Generic Name
Bone file/rasp, reciprocating, reusable FDA UDI
Device Name
BONE FILE MILLER 21" FDA UDI
Model / Reference
5257335 FDA UDI
Description
BONE FILE MILLER 21" FDA UDI

Identifiers

Primary DI / UDI-DI
00889813066874 FDA UDI
FDA Product Code
EMI FDA UDI
GMDN Term
Bone file/rasp, reciprocating, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone file/rasp, reciprocating, reusable

Darby Dental Supply, LLC by Darby Dental Supply, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone file/rasp, reciprocating, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Darby Dental Supply, Llc

Sources (1)

  • FDA UDI a3079d6e-b0f6-4200-9b26-b089e634ebe8 33 fields · synced May 30, 2026