Isovac2

FDA UDI

Class I (US FDA UDI)

by Zyris, Inc.

Identity

Trade Name: Isovac2 FDA UDI
Generic Name: Dental suction system FDA UDI
Device Name: Isovac2, Single FDA UDI
Model / Reference: EIV0201 FDA UDI
Description: Isovac2, Single FDA UDI

Identifiers

Catalog Number: EIV0201 FDA UDI
Primary DI / UDI-DI: 00810032660321 FDA UDI
FDA Product Code: EBR FDA UDI
GMDN Term: Dental suction system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental suction system

Isovac2 by Zyris, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental suction system.

Midmark — Midmark Corporation · Class I
Midmark — Midmark Corporation · Class I
BULL FROG SALIVA EJECTOR-STAINLESS STEELWITHOUT SWIVEL ADAPTOR — Hager Worldwide, Inc. · Class I
Mojave LT — Air Techniques, Inc. · Class I
H.V.E. VALVE BODY, EXTENDED (EACH) — Hager Worldwide, Inc. · Class I
Mojave — Air Techniques, Inc. · Class I
Midmark — Midmark Corporation · Class I
BaseVac — R. E. Morrison Equipment Inc · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Zyris, Inc.

Sources (1)

FDA UDI a975f351-7aa0-4470-b577-3c7886225f4f 35 fields · synced May 30, 2026