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Standard Burr 5.0mm

FDA UDI

Class II (US FDA UDI)

by RELIGN Corporation

Identity

Trade Name
Standard Burr 5.0mm FDA UDI
Generic Name
Orthopaedic bur, single-use FDA UDI
Device Name
Standard burr, disposable FDA UDI
Model / Reference
R-10021 FDA UDI
Description
Standard burr, disposable FDA UDI

Identifiers

Catalog Number
R-10021 FDA UDI
Primary DI / UDI-DI
00859273007212 FDA UDI
510(k) Number
K162770 FDA UDI
FDA Product Code
HRX FDA UDI
GEI FDA UDI
GMDN Term
Orthopaedic bur, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5.0 Millimeter FDA UDI

Category: Orthopaedic bur, single-use

Standard Burr 5.0mm by RELIGN Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bur, single-use.

Cleared under the same submission

K162770 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
RELIGN Corporation

Sources (1)

  • FDA UDI 75ef6e14-417f-4c2f-a50a-d6501c466828 37 fields · synced Jun 9, 2026