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De Soutter Medical

FDA UDI

Class I (US FDA UDI)

by De Soutter Medical, Ltd.

Identity

Trade Name
De Soutter Medical FDA UDI
Generic Name
Orthopaedic bur, single-use FDA UDI
Device Name
HST BUR - ROUND DIAMOND COARSE 2.0mm DIA x 152mm FDA UDI
Model / Reference
H51-1120 FDA UDI
Description
HST BUR - ROUND DIAMOND COARSE 2.0mm DIA x 152mm FDA UDI

Identifiers

Catalog Number
H51-1120 FDA UDI
Primary DI / UDI-DI
05051471090231 FDA UDI
FDA Product Code
GFF FDA UDI
GMDN Term
Orthopaedic bur, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 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

Yes

FDA UDI

Category: Orthopaedic bur, single-use

De Soutter Medical by De Soutter Medical, Ltd. — 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
De Soutter Medical, Ltd.

Sources (1)

  • FDA UDI cc47c51a-f6e2-4a39-b43d-027f7a0d0154 34 fields · synced May 31, 2026