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Reprocessed 3.1mm Standard Bur, Tapered Stainless Fluted

FDA UDI

Class I (US FDA UDI)

by Suretek Medical

Identity

Trade Name
Reprocessed 3.1mm Standard Bur, Tapered Stainless Fluted FDA UDI
Generic Name
Orthopaedic bur, single-use FDA UDI
Device Name
55 x 11 x 3.1mm, 8 Flute FDA UDI
Model / Reference
16-S0621 FDA UDI
Description
55 x 11 x 3.1mm, 8 Flute FDA UDI

Identifiers

Primary DI / UDI-DI
B39016S06211 FDA UDI
FDA Product Code
HTT FDA UDI
GMDN Term
Orthopaedic bur, single-use 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic bur, single-use

Reprocessed 3.1mm Standard Bur, Tapered Stainless Fluted by Suretek Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bur, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suretek Medical

Sources (1)

  • FDA UDI 51f9fcfa-9eaa-483a-820b-22bacda63006 33 fields · synced Jun 8, 2026