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Acu-Guard

FDA UDI

Class II (US FDA UDI)

by Acuderm, Inc.

Identity

Trade Name
ACU-GUARD FDA UDI
Generic Name
Medical equipment drape, single-use, non-sterile FDA UDI
Device Name
Acu-Guard II easy fit disposable clear sheaths non-sterile packaged 50/box FDA UDI
Model / Reference
ADG51 FDA UDI
Description
Acu-Guard II easy fit disposable clear sheaths non-sterile packaged 50/box FDA UDI

Identifiers

Primary DI / UDI-DI
10814105020859 FDA UDI
510(k) Number
K915000 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Medical equipment drape, single-use, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical equipment drape, single-use, non-sterile

Acu-Guard by Acuderm, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment drape, single-use, non-sterile.

Cleared under the same submission

K915000 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 8caa6921-6fd2-4595-87fa-c2ca010e8a13 35 fields · synced May 30, 2026