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Henry Schein

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Medical device-decontamination agent FDA UDI
Device Name
Maxizyme Enzymatic Detergent FDA UDI
Model / Reference
1019031 FDA UDI
Description
Maxizyme Enzymatic Detergent FDA UDI

Identifiers

Catalog Number
1019031 FDA UDI
Primary DI / UDI-DI
00304040006351 FDA UDI
FDA Product Code
MNL FDA UDI
GMDN Term
Medical device-decontamination agent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Dimensions & Sizes

Size
Total Volume — 1 Gallon FDA UDI

Category: Medical device-decontamination agent

Henry Schein by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical device-decontamination agent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI 229edded-3922-4843-abb3-2574c0c63283 36 fields · synced Jun 8, 2026