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Acu-Dispo-Curette

FDA UDI

Class I (US FDA UDI)

by Acuderm, Inc.

Identity

Trade Name
Acu-Dispo-Curette FDA UDI
Generic Name
Dermal curette, single-use FDA UDI
Device Name
Acu-Dispo-Curette 5mm, Single FDA UDI
Model / Reference
R05 FDA UDI
Description
Acu-Dispo-Curette 5mm, Single FDA UDI

Identifiers

Primary DI / UDI-DI
00814105020043 FDA UDI
510(k) Number
K891334 FDA UDI
FDA Product Code
FZS FDA UDI
GMDN Term
Dermal curette, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dermal curette, single-use

Acu-Dispo-Curette by Acuderm, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermal curette, single-use.

Cleared under the same submission

K891334 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acuderm, Inc.

Sources (1)

  • FDA UDI 58c5d059-f7c7-4f0a-855d-38b4ade0c431 34 fields · synced Jun 1, 2026