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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
DERMABRADER,CONE DIAMOND FDA UDI
Model / Reference
R27-110 FDA UDI
Description
DERMABRADER,CONE DIAMOND FDA UDI

Identifiers

Catalog Number
R27-110 FDA UDI
Primary DI / UDI-DI
05051471030091 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
Not 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

De Soutter Medical by De Soutter Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 09f96395-f31e-4bd7-9270-d60dad1b5ae5 35 fields · synced Jun 1, 2026